Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00352027

Enrollment

Registered

2006-07-14

Start date

2006-07-20

Completion date

2022-11-15

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's Disease

Brief summary

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Detailed description

Treatment Plan Description: Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11 Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9 Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage) Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11 Prednisone\* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12 G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) \* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

Interventions

DRUGVinblastine

Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.

DRUGNitrogen Mustard

Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.

DRUGAdriamycin®

Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.

DRUGCyclophosphamide

May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.

DRUGVincristine

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

DRUGBleomycin

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

DRUGEtoposide

Given IV on Days 1 and 2 of weeks 1-10.

DRUGPrednisone

Given PO every other day of weeks 1-12.

BIOLOGICALG-CSF

Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).

PROCEDURERadiotherapy

Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

Inclusion criteria

* Patient is less than or equal to 21 years of age * Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma * Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion criteria

* Patients with favorable risk features * Patients with unfavorable risk features * Patients who have received prior therapy for Hodgkin lymphoma.

Design outcomes

Primary

Measure	Time frame	Description
3-year Event-Free Survival Probability	3 years	The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.

Secondary

Measure	Time frame	Description
Disease Failure Rate Within Radiation Fields	3 years	Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
Local and Distant Failure for Children Treated With Tailored-field Radiation	from first enrollment date up to 3 years follow-up	The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.
Prognostic Factors for Treatment Failure: Age	5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up	Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.
Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Total Score	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Nausea	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Worry	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), PedsQL v.3.0: Communication	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Patient Quality of Life (QoL), Symptom Distress Scale	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	The patient's degree of discomfort from specific treatment-related symptoms across multiple time points. Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
3-year Overall Survival (OS) Probability	3-years	Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score	6 months after the completion of therapy	Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning	6 months after the completion of therapy	Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health	6 months after the completion of therapy	Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning	6 months after the completion of therapy	Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning	6 months after the completion of therapy	Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning	6 months after the completion of therapy	Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication	6 months after the completion of therapy	Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.
3-year Event-free Survival (EFS) Probability	3 years	Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.
Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Toxicities With Grade >1	3 years	Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Prognostic Factors for Treatment Failure: Gender	3 years follow-up	Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.
Prognostic Factors for Treatment Failure: Histology	3 years follow-up	Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.
Prognostic Factors for Treatment Failure: Stage	5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up	Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage \<III showed a better outcome but was not statistically significant.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	1, 2, 5, and 10 years post therapy	Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	1, 2, 5, and 10 years post therapy	Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	1, 2, 5, and 10 years post therapy	Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	1, 2, 5, and 10 years post therapy	For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings.
3-year Local Failure-free Survival Probability	3 years	Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled between July 2006 and March 2012.

Pre-assignment details

One participant was determined to be ineligible after enrollment and prior to start of therapy.

Participants by arm

Arm	Count
Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	80
Total	80

Arm

Count

Stanford V Chemotherapy

Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Progressive disease	3

Baseline characteristics

Characteristic	Stanford V Chemotherapy
Age, Continuous	15.10 years STANDARD_DEVIATION 3.15
Participating Site Location Dana Farber Cancer Institute, Boston, MA	21 participants
Participating Site Location Main Medical Center, Portland, ME	2 participants
Participating Site Location Massachusetts General Hospital, Boston, MA	1 participants
Participating Site Location Rady Children's Hospital, San Diego, CA	1 participants
Participating Site Location Stanford University Medical Center, Palo Alto, CA	22 participants
Participating Site Location St. Jude Children's Research Hospital, Memphis, TN	33 participants
Sex: Female, Male Female	46 Participants
Sex: Female, Male Male	34 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	69 / 80
serious Total, serious adverse events	1 / 80

Outcome results

Primary

3-year Event-Free Survival Probability

The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.

Time frame: 3 years

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	3-year Event-Free Survival Probability	0.887 probability

Comparison: The association of age with EFS was compared. P values from Score test were computed for the statistical significance.p-value: 0.997Cox Model

Secondary

3-year Event-free Survival (EFS) Probability

Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Time frame: 3 years

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	3-year Event-free Survival (EFS) Probability	0.887 probability
Week 8	3-year Event-free Survival (EFS) Probability	0.844 probability

p-value: 0.908Log Rank

Secondary

3-year Local Failure-free Survival Probability

Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Time frame: 3 years

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	3-year Local Failure-free Survival Probability	0.887 probability
Week 8	3-year Local Failure-free Survival Probability	0.932 probability

p-value: 0.411Log Rank

Secondary

3-year Overall Survival (OS) Probability

Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Time frame: 3-years

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	3-year Overall Survival (OS) Probability	1.00 probability
Week 8	3-year Overall Survival (OS) Probability	0.978 probability

p-value: 0.178Log Rank

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time frame: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems	-1.46 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication	-1.35 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea	-2.31 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt	-2.52 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance	-1.20 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety	-0.87 beta coefficient

p-value: 0.005Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score	-1.41 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety	-0.96 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry

Time frame: 6 months after the completion of therapy

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry	-1.06 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time frame: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning	-1.56 beta coefficient

p-value: <0.001Generallized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning

Time frame: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning	-1.9 beta coefficient

p-value: <0.001Generallized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health

Time frame: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health	-0.92 beta coefficient

p-value: <0.001Generallized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning

Time frame: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning	-1.21 beta coefficient

p-value: <0.001Generallized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning

Time frame: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning	-0.79 beta coefficient

p-value: <0.001Generallized Estimating Equations (GEE)

Secondary

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score

Time frame: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score	-1.46 beta coefficient

p-value: <0.001Generalized Estimating Equations (GEE)

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems	-1.0 units on a scale	Standard Deviation 20.7
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems	0.14 units on a scale	Standard Deviation 19
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems	-8.0 units on a scale	Standard Deviation 19
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems	-4.0 units on a scale	Standard Deviation 20

p-value: 0.933Wilcoxon Signed Rank Test

p-value: 0.051Wilcoxon Signed Rank Test

p-value: 0.0779Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication	-0.3 units on a scale	Standard Deviation 26.4
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication	-3.6 units on a scale	Standard Deviation 25.2
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication	-7.4 units on a scale	Standard Deviation 25.5
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication	-6.3 units on a scale	Standard Deviation 21.1

p-value: 0.814Wilcoxon Signed Rank Test

p-value: 0.553Wilcoxon Signed Rank Test

p-value: 0.173Wilcoxon Signed Rank Test

p-value: 0.122Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea	-1.2 units on a scale	Standard Deviation 15.8
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea	-3.4 units on a scale	Standard Deviation 21.9
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea	-3.0 units on a scale	Standard Deviation 22.4
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea	-1.1 units on a scale	Standard Deviation 22.2

p-value: 0.629Wilcoxon Signed Rank Test

p-value: 0.858Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt	-2.0 units on a scale	Standard Deviation 16.5
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt	-9.5 units on a scale	Standard Deviation 23.6
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt	-5.6 units on a scale	Standard Deviation 23.4
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt	-5.4 units on a scale	Standard Deviation 19.8

p-value: 0.381Wilcoxon Signed Rank Test

p-value: 0.006Wilcoxon Signed Rank Test

p-value: 0.277Wilcoxon Signed Rank Test

p-value: 0.134Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance	-2.5 units on a scale	Standard Deviation 21
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance	-9.5 units on a scale	Standard Deviation 22.5
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance	-5.9 units on a scale	Standard Deviation 25.7
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance	-9.3 units on a scale	Standard Deviation 20.5

p-value: 0.415Wilcoxon Signed Rank Test

p-value: 0.005Wilcoxon Signed Rank Test

p-value: 0.245Wilcoxon Signed Rank Test

p-value: 0.005Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety	-0.2 units on a scale	Standard Deviation 28.1
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety	-9.3 units on a scale	Standard Deviation 29.9
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety	-2.2 units on a scale	Standard Deviation 32.7
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety	-8.7 units on a scale	Standard Deviation 27.7

p-value: 0.744Wilcoxon Signed Rank Test

p-value: 0.075Wilcoxon Signed Rank Test

p-value: 0.512Wilcoxon Signed Rank Test

p-value: 0.088Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score	-1.5 units on a scale	Standard Deviation 13
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score	-5.2 units on a scale	Standard Deviation 13.8
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score	-4.5 units on a scale	Standard Deviation 12.5
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score	-5 units on a scale	Standard Deviation 16.8

p-value: 0.162Wilcoxon Signed Rank Test

p-value: 0.558Wilcoxon Signed Rank Test

p-value: 0.039Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety	-6.1 units on a scale	Standard Deviation 21.9
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety	-8.8 units on a scale	Standard Deviation 26.4
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety	-7.9 units on a scale	Standard Deviation 23.7
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety	-6.6 units on a scale	Standard Deviation 26.7

p-value: 0.078Wilcoxon Signed Rank Test

p-value: 0.041Wilcoxon Signed Rank Test

p-value: 0.078Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry	-0.7 units on a scale	Standard Deviation 21.7
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry	-3.9 units on a scale	Standard Deviation 26.5
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry	-2.7 units on a scale	Standard Deviation 20.4
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry	-0.5 units on a scale	Standard Deviation 19.9

p-value: 0.739Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	-4.9 units on a scale	Standard Deviation 18.8
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	-9.4 units on a scale	Standard Deviation 17.9
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	-8.0 units on a scale	Standard Deviation 14.2
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	-10.8 units on a scale	Standard Deviation 14.3
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	-1.7 units on a scale	Standard Deviation 18.8

p-value: 0.071Wilcoxon Signed Rank Test

p-value: <0.001Wilcoxon Signed Rank Test

p-value: 0.707Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	-2.9 units on a scale	Standard Deviation 16.4
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	-2.3 units on a scale	Standard Deviation 16.9
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	-1.9 units on a scale	Standard Deviation 23.3
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	-5.4 units on a scale	Standard Deviation 15.8
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	-2 units on a scale	Standard Deviation 19.1

p-value: 0.563Wilcoxon Signed Rank Test

p-value: 0.184Wilcoxon Signed Rank Test

p-value: 0.563Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	-2.8 units on a scale	Standard Deviation 14.4
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	-6.4 units on a scale	Standard Deviation 14.4
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	-6.3 units on a scale	Standard Deviation 13.2
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	-5.6 units on a scale	Standard Deviation 11.2
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	-3.3 units on a scale	Standard Deviation 14.2

p-value: 0.319Wilcoxon Signed Rank Test

p-value: 0.01Wilcoxon Signed Rank Test

p-value: 0.002Wilcoxon Signed Rank Test

p-value: 0.015Wilcoxon Signed Rank Test

p-value: 0.588Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	1.3 units on a scale	Standard Deviation 17
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	-5.3 units on a scale	Standard Deviation 19.5
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	-4.1 units on a scale	Standard Deviation 21
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	-3.4 units on a scale	Standard Deviation 16.7
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	-4.3 units on a scale	Standard Deviation 16.4

p-value: 0.503Wilcoxon Signed Rank Test

p-value: 0.372Wilcoxon Signed Rank Test

p-value: 0.546Wilcoxon Signed Rank Test

p-value: 0.242Wilcoxon Signed Rank Test

p-value: 0.372Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	-5.3 units on a scale	Standard Deviation 16.5
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	-5.7 units on a scale	Standard Deviation 15.3
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	-7.4 units on a scale	Standard Deviation 17.7
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	-5.0 units on a scale	Standard Deviation 12.6
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	-3.3 units on a scale	Standard Deviation 16.4

p-value: 0.042Wilcoxon Signed Rank Test

p-value: 0.025Wilcoxon Signed Rank Test

p-value: 0.013Wilcoxon Signed Rank Test

p-value: 0.027Wilcoxon Signed Rank Test

p-value: 0.243Wilcoxon Signed Rank Test

Secondary

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	-2.9 units on a scale	Standard Deviation 13.3
Week 8	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	-4.8 units on a scale	Standard Deviation 13.8
Week 12	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	-4.8 units on a scale	Standard Deviation 14.7
After Radiation	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	-5 units on a scale	Standard Deviation 10.7
Off-therapy	Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	-2.9 units on a scale	Standard Deviation 14.8

p-value: 0.265Wilcoxon Signed Rank Test

p-value: 0.057Wilcoxon Signed Rank Test

p-value: 0.079Wilcoxon Signed Rank Test

p-value: 0.025Wilcoxon Signed Rank Test

p-value: 0.68Wilcoxon Signed Rank Test

Secondary

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)

Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.

Time frame: 1, 2, 5, and 10 years post therapy

Population: At each time point, a participant underwent an Echocardiogram (ECHO). Data was unavailable for patients who did not undergo the Echocardiogram at that time point.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Normal	68 Participants
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Abnormal	0 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Abnormal	1 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Normal	57 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Normal	36 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Abnormal	2 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Normal	15 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Abnormal	1 Participants

Secondary

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)

Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.

Time frame: 1, 2, 5, and 10 years post therapy

Population: At each time point, a participant underwent an Electrocardiogram (EKG). Data was unavailable for patients who did not undergo the Electrocardiogram at that time point.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Normal	51 Participants
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Abnormal	5 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Abnormal	8 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Normal	44 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Normal	24 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Abnormal	4 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Normal	10 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Abnormal	6 Participants

Secondary

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)

Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.

Time frame: 1, 2, 5, and 10 years post therapy

Population: At each time point, participants who received mediastinal/lung radiation or bleomycin underwent pulmonary function (PFT) assessment. Data was unavailable for patients who did not undergo the pulmonary function test at that time point.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Normal	46 Participants
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Abnormal	20 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Abnormal	20 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Normal	41 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Normal	25 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Abnormal	11 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Normal	9 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Abnormal	1 Participants

Secondary

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)

For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings.

Time frame: 1, 2, 5, and 10 years post therapy

Population: At each time point, participants who received cervical and upper mediastinal radiation underwent TSH laboratory test. Data was unavailable for patients who did not undergo the TSH test at that time point.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hypothyroid	8 Participants
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Normal	60 Participants
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Thyroid Nodule	0 Participants
Stanford V Chemotherapy	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hyperthyroid	2 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Normal	54 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hypothyroid	11 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hyperthyroid	1 Participants
Week 8	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Thyroid Nodule	0 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Normal	37 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hyperthyroid	1 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hypothyroid	8 Participants
Week 12	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Thyroid Nodule	0 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hypothyroid	3 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Hyperthyroid	0 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Thyroid Nodule	0 Participants
After Radiation	Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	Normal	20 Participants

Secondary

Disease Failure Rate Within Radiation Fields

Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).

Time frame: 3 years

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Disease Failure Rate Within Radiation Fields	0.1125 proportion of participants

Secondary

Local and Distant Failure for Children Treated With Tailored-field Radiation

The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.

Time frame: from first enrollment date up to 3 years follow-up

Arm	Measure	Group	Value (NUMBER)
Stanford V Chemotherapy	Local and Distant Failure for Children Treated With Tailored-field Radiation	Cumulative incidence of distant failure at 3 years	0.0375 probability that the event occurs
Stanford V Chemotherapy	Local and Distant Failure for Children Treated With Tailored-field Radiation	Cumulative incidence of local failure at 3 years	0.1127 probability that the event occurs

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	77.6 units on a scale	Standard Deviation 21.8
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	79.5 units on a scale	Standard Deviation 20.4
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	78.6 units on a scale	Standard Deviation 21.8
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	79.9 units on a scale	Standard Deviation 23.4

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication	79.2 units on a scale	Standard Deviation 25.9
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication	80.4 units on a scale	Standard Deviation 24.9
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication	80.3 units on a scale	Standard Deviation 22.6
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication	84.3 units on a scale	Standard Deviation 20.3

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea	61.2 units on a scale	Standard Deviation 24.4
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea	57.4 units on a scale	Standard Deviation 29.2
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea	72.2 units on a scale	Standard Deviation 26.6
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea	83.2 units on a scale	Standard Deviation 22.6

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	61.2 units on a scale	Standard Deviation 24.3
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	61.8 units on a scale	Standard Deviation 30.5
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	73.1 units on a scale	Standard Deviation 25.9
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	82.7 units on a scale	Standard Deviation 23.4

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	74.9 units on a scale	Standard Deviation 22.9
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	72.2 units on a scale	Standard Deviation 21.9
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	73.7 units on a scale	Standard Deviation 24.2
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	76.3 units on a scale	Standard Deviation 24.4

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	70.0 units on a scale	Standard Deviation 32.1
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	60.0 units on a scale	Standard Deviation 35
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	63.1 units on a scale	Standard Deviation 36.6
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	73.8 units on a scale	Standard Deviation 31.7

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score	71.7 units on a scale	Standard Deviation 16.7
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score	69.3 units on a scale	Standard Deviation 19
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score	74.5 units on a scale	Standard Deviation 17.7
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score	80.0 units on a scale	Standard Deviation 16.4

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	81.9 units on a scale	Standard Deviation 21.8
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	72.6 units on a scale	Standard Deviation 28.4
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	78.5 units on a scale	Standard Deviation 26.8
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	81.8 units on a scale	Standard Deviation 20.8

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry	70 units on a scale	Standard Deviation 24.5
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry	69.2 units on a scale	Standard Deviation 25.3
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry	71.9 units on a scale	Standard Deviation 24.1
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry	78.7 units on a scale	Standard Deviation 19.4

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	67.7 units on a scale	Standard Deviation 20.4
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	65.4 units on a scale	Standard Deviation 18.4
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	68.1 units on a scale	Standard Deviation 23.7
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	73.0 units on a scale	Standard Deviation 20.1
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	82.0 units on a scale	Standard Deviation 18.9

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	79.8 units on a scale	Standard Deviation 20.7
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	65.3 units on a scale	Standard Deviation 23.2
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	67.3 units on a scale	Standard Deviation 25.2
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	73.6 units on a scale	Standard Deviation 21.3
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	84.6 units on a scale	Standard Deviation 18.6

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	76.2 units on a scale	Standard Deviation 16.8
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	71.0 units on a scale	Standard Deviation 16.7
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	74.1 units on a scale	Standard Deviation 17.9
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	79.0 units on a scale	Standard Deviation 16.1
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	88.0 units on a scale	Standard Deviation 17

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	74.4 units on a scale	Standard Deviation 20.6
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	62.8 units on a scale	Standard Deviation 25
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	70.8 units on a scale	Standard Deviation 22.7
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	75.6 units on a scale	Standard Deviation 20.8
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	78.9 units on a scale	Standard Deviation 21.2

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	86.1 units on a scale	Standard Deviation 18.6
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	83.0 units on a scale	Standard Deviation 16
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	80.7 units on a scale	Standard Deviation 18.5
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	85.1 units on a scale	Standard Deviation 16.3
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	89.1 units on a scale	Standard Deviation 16.8

Secondary

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	77.6 units on a scale	Standard Deviation 16.7
Week 8	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	69.1 units on a scale	Standard Deviation 17.9
Week 12	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	72.3 units on a scale	Standard Deviation 18.5
After Radiation	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	77.8 units on a scale	Standard Deviation 16.3
Off-therapy	Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	83.5 units on a scale	Standard Deviation 16.4

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	79.1 units on a scale	Standard Deviation 19.4
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	78.2 units on a scale	Standard Deviation 21.4
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	87.0 units on a scale	Standard Deviation 17.3
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	82.0 units on a scale	Standard Deviation 23.2

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Communication

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Communication	80.7 units on a scale	Standard Deviation 19.9
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Communication	83.0 units on a scale	Standard Deviation 22.5
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Communication	87.2 units on a scale	Standard Deviation 22.8
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Communication	89.0 units on a scale	Standard Deviation 19.3

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Nausea

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Nausea	62.7 units on a scale	Standard Deviation 24
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Nausea	60.1 units on a scale	Standard Deviation 23.5
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Nausea	76.7 units on a scale	Standard Deviation 20.9
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Nausea	81.6 units on a scale	Standard Deviation 23.1

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	63.9 units on a scale	Standard Deviation 25.4
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	71.5 units on a scale	Standard Deviation 24.6
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	79.9 units on a scale	Standard Deviation 25.1
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	88.0 units on a scale	Standard Deviation 17.8

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	77.6 units on a scale	Standard Deviation 22.1
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	81.3 units on a scale	Standard Deviation 22.6
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	81.4 units on a scale	Standard Deviation 22.4
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	84.7 units on a scale	Standard Deviation 22.9

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	71.8 units on a scale	Standard Deviation 29
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	70.9 units on a scale	Standard Deviation 32.6
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	68.1 units on a scale	Standard Deviation 37.3
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	80.1 units on a scale	Standard Deviation 25.9

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Total Score

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Total Score	74.1 units on a scale	Standard Deviation 15.3
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Total Score	74.2 units on a scale	Standard Deviation 16.8
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Total Score	81.7 units on a scale	Standard Deviation 14.6
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Total Score	83.5 units on a scale	Standard Deviation 17.2

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	89.2 units on a scale	Standard Deviation 15.5
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	82 units on a scale	Standard Deviation 22.5
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	89.4 units on a scale	Standard Deviation 16.6
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	87.3 units on a scale	Standard Deviation 19.1

Secondary

Patient Quality of Life (QoL), PedsQL v.3.0: Worry

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Arm	Measure	Value (MEAN)	Dispersion
Week 8	Patient Quality of Life (QoL), PedsQL v.3.0: Worry	71.2 units on a scale	Standard Deviation 22.5
Week 12	Patient Quality of Life (QoL), PedsQL v.3.0: Worry	72.2 units on a scale	Standard Deviation 24.7
After Radiation	Patient Quality of Life (QoL), PedsQL v.3.0: Worry	74.5 units on a scale	Standard Deviation 27.2
Off-therapy	Patient Quality of Life (QoL), PedsQL v.3.0: Worry	76.0 units on a scale	Standard Deviation 25

Secondary

Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	72.6 units on a scale	Standard Deviation 18
Week 8	Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	75.3 units on a scale	Standard Deviation 19.3
Week 12	Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	75.7 units on a scale	Standard Deviation 20.8
After Radiation	Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	84.5 units on a scale	Standard Deviation 17.8
Off-therapy	Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	81.6 units on a scale	Standard Deviation 24.1

Secondary

Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	83.2 units on a scale	Standard Deviation 17.1
Week 8	Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	68.4 units on a scale	Standard Deviation 23.1
Week 12	Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	69.1 units on a scale	Standard Deviation 24.6
After Radiation	Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	80.8 units on a scale	Standard Deviation 17.1
Off-therapy	Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	85.2 units on a scale	Standard Deviation 15.6

Secondary

Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	79.3 units on a scale	Standard Deviation 13
Week 8	Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	77.6 units on a scale	Standard Deviation 15.4
Week 12	Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	78.6 units on a scale	Standard Deviation 16.8
After Radiation	Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	84.3 units on a scale	Standard Deviation 15.1
Off-therapy	Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	84.3 units on a scale	Standard Deviation 17.9

Secondary

Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	73.1 units on a scale	Standard Deviation 18.8
Week 8	Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	69.5 units on a scale	Standard Deviation 21.8
Week 12	Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	72.6 units on a scale	Standard Deviation 22.2
After Radiation	Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	78.4 units on a scale	Standard Deviation 20.6
Off-therapy	Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	81.3 units on a scale	Standard Deviation 21.6

Secondary

Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	90.9 units on a scale	Standard Deviation 11.1
Week 8	Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	88.6 units on a scale	Standard Deviation 13
Week 12	Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	88.0 units on a scale	Standard Deviation 15.6
After Radiation	Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	90.1 units on a scale	Standard Deviation 12.5
Off-therapy	Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	91.1 units on a scale	Standard Deviation 13.6

Secondary

Patient Quality of Life (QoL), PedsQL v.4.0: Total Score

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	80.9 units on a scale	Standard Deviation 12.7
Week 8	Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	74.4 units on a scale	Standard Deviation 16.5
Week 12	Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	75.3 units on a scale	Standard Deviation 17.8
After Radiation	Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	83.1 units on a scale	Standard Deviation 14.6
Off-therapy	Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	84.5 units on a scale	Standard Deviation 16.6

Secondary

Patient Quality of Life (QoL), Symptom Distress Scale

The patient's degree of discomfort from specific treatment-related symptoms across multiple time points. Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Arm	Measure	Value (MEAN)	Dispersion
Stanford V Chemotherapy	Patient Quality of Life (QoL), Symptom Distress Scale	17.3 units on a scale	Standard Deviation 6.5
Week 8	Patient Quality of Life (QoL), Symptom Distress Scale	19.6 units on a scale	Standard Deviation 6.6
Week 12	Patient Quality of Life (QoL), Symptom Distress Scale	18.1 units on a scale	Standard Deviation 6.1
After Radiation	Patient Quality of Life (QoL), Symptom Distress Scale	15.1 units on a scale	Standard Deviation 4.8
Off-therapy	Patient Quality of Life (QoL), Symptom Distress Scale	14.3 units on a scale	Standard Deviation 5.3

Secondary

Prognostic Factors for Treatment Failure: Age

Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.

Time frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Arm	Measure	Value (NUMBER)
Stanford V Chemotherapy	Prognostic Factors for Treatment Failure: Age	11 events

p-value: 0.997Cox Model

Secondary

Prognostic Factors for Treatment Failure: Gender

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.

Time frame: 3 years follow-up

Arm	Measure	Group	Value (NUMBER)
Stanford V Chemotherapy	Prognostic Factors for Treatment Failure: Gender	Male	5 events
Stanford V Chemotherapy	Prognostic Factors for Treatment Failure: Gender	Female	6 events

p-value: 0.4318Cox Model

Secondary

Prognostic Factors for Treatment Failure: Histology

Time frame: 3 years follow-up

Arm	Measure	Group	Value (NUMBER)
Stanford V Chemotherapy	Prognostic Factors for Treatment Failure: Histology	Classical, Nodular Sclerosing	10 events
Stanford V Chemotherapy	Prognostic Factors for Treatment Failure: Histology	Other	1 events

p-value: 0.2199Cox Model

Secondary

Prognostic Factors for Treatment Failure: Stage

Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage \<III showed a better outcome but was not statistically significant.

Time frame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Arm	Measure	Group	Value (NUMBER)
Stanford V Chemotherapy	Prognostic Factors for Treatment Failure: Stage	Stage <III	8 events
Stanford V Chemotherapy	Prognostic Factors for Treatment Failure: Stage	Stage ≥III	3 events

p-value: 0.8946Cox Model

Secondary

Toxicities With Grade >1

Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Time frame: 3 years

Population: Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date.

Arm	Measure	Group	Value (NUMBER)
Stanford V Chemotherapy	Toxicities With Grade >1	Hemoglobin	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Constipation	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Alanine transaminase (ALT)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Aspartate transaminase (AST)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Allergic reaction/hypersensitivity	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Febrile neutropenia	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Fever (in the absence of neutropenia)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Glucose	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Hypoxia	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Infection - Other	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Infection with unknown ANC	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Insomnia	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Leukocytes (total WBC)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Lymphopenia	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Nausea	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Neuropathy: motor	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Neuropathy: sensory	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Pain	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Phosphate	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Platelets	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Potassium	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Sodium	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Syndromes - Other	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Thrombosis/thrombus/embolism	0 adverse events
Stanford V Chemotherapy	Toxicities With Grade >1	Vomiting	0 adverse events
Week 8	Toxicities With Grade >1	Constipation	0 adverse events
Week 8	Toxicities With Grade >1	Hemoglobin	26 adverse events
Week 8	Toxicities With Grade >1	Infection with unknown ANC	0 adverse events
Week 8	Toxicities With Grade >1	Vomiting	2 adverse events
Week 8	Toxicities With Grade >1	Febrile neutropenia	7 adverse events
Week 8	Toxicities With Grade >1	Sodium	1 adverse events
Week 8	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	2 adverse events
Week 8	Toxicities With Grade >1	Platelets	0 adverse events
Week 8	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	2 adverse events
Week 8	Toxicities With Grade >1	Hypoxia	1 adverse events
Week 8	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	24 adverse events
Week 8	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	1 adverse events
Week 8	Toxicities With Grade >1	Potassium	2 adverse events
Week 8	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	0 adverse events
Week 8	Toxicities With Grade >1	Allergic reaction/hypersensitivity	4 adverse events
Week 8	Toxicities With Grade >1	Insomnia	1 adverse events
Week 8	Toxicities With Grade >1	Aspartate transaminase (AST)	1 adverse events
Week 8	Toxicities With Grade >1	Glucose	0 adverse events
Week 8	Toxicities With Grade >1	Neuropathy: sensory	1 adverse events
Week 8	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	3 adverse events
Week 8	Toxicities With Grade >1	Pain	5 adverse events
Week 8	Toxicities With Grade >1	Nausea	1 adverse events
Week 8	Toxicities With Grade >1	Phosphate	1 adverse events
Week 8	Toxicities With Grade >1	Leukocytes (total WBC)	41 adverse events
Week 8	Toxicities With Grade >1	Alanine transaminase (ALT)	1 adverse events
Week 8	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	1 adverse events
Week 8	Toxicities With Grade >1	Thrombosis/thrombus/embolism	0 adverse events
Week 8	Toxicities With Grade >1	Fever (in the absence of neutropenia)	2 adverse events
Week 8	Toxicities With Grade >1	Lymphopenia	22 adverse events
Week 8	Toxicities With Grade >1	Syndromes - Other	1 adverse events
Week 8	Toxicities With Grade >1	Infection - Other	1 adverse events
Week 8	Toxicities With Grade >1	Neuropathy: motor	0 adverse events
Week 12	Toxicities With Grade >1	Pain	0 adverse events
Week 12	Toxicities With Grade >1	Leukocytes (total WBC)	15 adverse events
Week 12	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	0 adverse events
Week 12	Toxicities With Grade >1	Lymphopenia	7 adverse events
Week 12	Toxicities With Grade >1	Thrombosis/thrombus/embolism	1 adverse events
Week 12	Toxicities With Grade >1	Aspartate transaminase (AST)	0 adverse events
Week 12	Toxicities With Grade >1	Glucose	0 adverse events
Week 12	Toxicities With Grade >1	Alanine transaminase (ALT)	0 adverse events
Week 12	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	0 adverse events
Week 12	Toxicities With Grade >1	Syndromes - Other	0 adverse events
Week 12	Toxicities With Grade >1	Sodium	0 adverse events
Week 12	Toxicities With Grade >1	Hemoglobin	6 adverse events
Week 12	Toxicities With Grade >1	Hypoxia	0 adverse events
Week 12	Toxicities With Grade >1	Potassium	0 adverse events
Week 12	Toxicities With Grade >1	Vomiting	0 adverse events
Week 12	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	0 adverse events
Week 12	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	0 adverse events
Week 12	Toxicities With Grade >1	Constipation	0 adverse events
Week 12	Toxicities With Grade >1	Platelets	0 adverse events
Week 12	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	0 adverse events
Week 12	Toxicities With Grade >1	Phosphate	0 adverse events
Week 12	Toxicities With Grade >1	Allergic reaction/hypersensitivity	0 adverse events
Week 12	Toxicities With Grade >1	Infection - Other	0 adverse events
Week 12	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	0 adverse events
Week 12	Toxicities With Grade >1	Fever (in the absence of neutropenia)	0 adverse events
Week 12	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	32 adverse events
Week 12	Toxicities With Grade >1	Infection with unknown ANC	0 adverse events
Week 12	Toxicities With Grade >1	Neuropathy: sensory	0 adverse events
Week 12	Toxicities With Grade >1	Neuropathy: motor	0 adverse events
Week 12	Toxicities With Grade >1	Insomnia	0 adverse events
Week 12	Toxicities With Grade >1	Febrile neutropenia	1 adverse events
Week 12	Toxicities With Grade >1	Nausea	0 adverse events
After Radiation	Toxicities With Grade >1	Insomnia	0 adverse events
After Radiation	Toxicities With Grade >1	Sodium	0 adverse events
After Radiation	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	0 adverse events
After Radiation	Toxicities With Grade >1	Infection - Other	0 adverse events
After Radiation	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	0 adverse events
After Radiation	Toxicities With Grade >1	Alanine transaminase (ALT)	0 adverse events
After Radiation	Toxicities With Grade >1	Pain	0 adverse events
After Radiation	Toxicities With Grade >1	Syndromes - Other	0 adverse events
After Radiation	Toxicities With Grade >1	Febrile neutropenia	0 adverse events
After Radiation	Toxicities With Grade >1	Glucose	0 adverse events
After Radiation	Toxicities With Grade >1	Neuropathy: motor	0 adverse events
After Radiation	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	0 adverse events
After Radiation	Toxicities With Grade >1	Nausea	0 adverse events
After Radiation	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	0 adverse events
After Radiation	Toxicities With Grade >1	Constipation	0 adverse events
After Radiation	Toxicities With Grade >1	Thrombosis/thrombus/embolism	0 adverse events
After Radiation	Toxicities With Grade >1	Aspartate transaminase (AST)	0 adverse events
After Radiation	Toxicities With Grade >1	Hypoxia	0 adverse events
After Radiation	Toxicities With Grade >1	Neuropathy: sensory	0 adverse events
After Radiation	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	0 adverse events
After Radiation	Toxicities With Grade >1	Lymphopenia	0 adverse events
After Radiation	Toxicities With Grade >1	Platelets	0 adverse events
After Radiation	Toxicities With Grade >1	Leukocytes (total WBC)	0 adverse events
After Radiation	Toxicities With Grade >1	Potassium	0 adverse events
After Radiation	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	0 adverse events
After Radiation	Toxicities With Grade >1	Vomiting	0 adverse events
After Radiation	Toxicities With Grade >1	Infection with unknown ANC	0 adverse events
After Radiation	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	0 adverse events
After Radiation	Toxicities With Grade >1	Allergic reaction/hypersensitivity	0 adverse events
After Radiation	Toxicities With Grade >1	Hemoglobin	0 adverse events
After Radiation	Toxicities With Grade >1	Phosphate	0 adverse events
After Radiation	Toxicities With Grade >1	Fever (in the absence of neutropenia)	0 adverse events
Off-therapy	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	0 adverse events
Off-therapy	Toxicities With Grade >1	Febrile neutropenia	0 adverse events
Off-therapy	Toxicities With Grade >1	Fever (in the absence of neutropenia)	0 adverse events
Off-therapy	Toxicities With Grade >1	Glucose	0 adverse events
Off-therapy	Toxicities With Grade >1	Hemoglobin	0 adverse events
Off-therapy	Toxicities With Grade >1	Hypoxia	0 adverse events
Off-therapy	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	0 adverse events
Off-therapy	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	0 adverse events
Off-therapy	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	0 adverse events
Off-therapy	Toxicities With Grade >1	Infection - Other	0 adverse events
Off-therapy	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	0 adverse events
Off-therapy	Toxicities With Grade >1	Infection with unknown ANC	0 adverse events
Off-therapy	Toxicities With Grade >1	Insomnia	0 adverse events
Off-therapy	Toxicities With Grade >1	Leukocytes (total WBC)	0 adverse events
Off-therapy	Toxicities With Grade >1	Lymphopenia	0 adverse events
Off-therapy	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	0 adverse events
Off-therapy	Toxicities With Grade >1	Nausea	0 adverse events
Off-therapy	Toxicities With Grade >1	Thrombosis/thrombus/embolism	0 adverse events
Off-therapy	Toxicities With Grade >1	Neuropathy: motor	0 adverse events
Off-therapy	Toxicities With Grade >1	Neuropathy: sensory	0 adverse events
Off-therapy	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	0 adverse events
Off-therapy	Toxicities With Grade >1	Pain	0 adverse events
Off-therapy	Toxicities With Grade >1	Phosphate	0 adverse events
Off-therapy	Toxicities With Grade >1	Platelets	0 adverse events
Off-therapy	Toxicities With Grade >1	Potassium	0 adverse events
Off-therapy	Toxicities With Grade >1	Sodium	0 adverse events
Off-therapy	Toxicities With Grade >1	Vomiting	1 adverse events
Off-therapy	Toxicities With Grade >1	Alanine transaminase (ALT)	0 adverse events
Off-therapy	Toxicities With Grade >1	Aspartate transaminase (AST)	0 adverse events
Off-therapy	Toxicities With Grade >1	Syndromes - Other	0 adverse events
Off-therapy	Toxicities With Grade >1	Allergic reaction/hypersensitivity	0 adverse events
Off-therapy	Toxicities With Grade >1	Constipation	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Constipation	1 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Syndromes - Other	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Vomiting	4 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Febrile neutropenia	5 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Alanine transaminase (ALT)	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Glucose	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Insomnia	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Thrombosis/thrombus/embolism	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Lymphopenia	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Aspartate transaminase (AST)	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	1 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Pain	1 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Leukocytes (total WBC)	19 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Nausea	2 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Infection with unknown ANC	1 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Infection - Other	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Fever (in the absence of neutropenia)	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Phosphate	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Neuropathy: sensory	1 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	2 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Allergic reaction/hypersensitivity	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Platelets	3 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Hypoxia	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Neuropathy: motor	1 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Potassium	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Hemoglobin	2 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	1 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Sodium	0 adverse events
HOD99 - Grade 3	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	9 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Hypoxia	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Syndromes - Other	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	30 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Glucose	1 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Constipation	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Sodium	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Alanine transaminase (ALT)	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Neuropathy: motor	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Phosphate	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Allergic reaction/hypersensitivity	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Fever (in the absence of neutropenia)	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Neuropathy: sensory	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Infection - Other	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Lymphopenia	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Infection with unknown ANC	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Leukocytes (total WBC)	5 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Potassium	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Hemoglobin	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Platelets	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Vomiting	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Pain	1 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Insomnia	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Aspartate transaminase (AST)	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Febrile neutropenia	2 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Nausea	0 adverse events
HOD99 - Grade 4	Toxicities With Grade >1	Thrombosis/thrombus/embolism	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Allergic reaction/hypersensitivity	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Thrombosis/embolism (vascular access-related)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Infection with unknown ANC	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Neuropathy: motor	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Neuropathy: sensory	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Infection with normal ANC or Grade 1-2 neutrophils	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Neutrophils/granulocytes (ANC/AGC)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Thrombosis/thrombus/embolism	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Infection - Other	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Febrile neutropenia	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Pain	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Vomiting	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Infection with Grade 3 or 4 neutrophils	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Phosphate	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Ileus, GI (functional obstruction of bowel)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Platelets	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Hypoxia	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Hemoglobin	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Potassium	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	GGT (gamma-Glutamyltranspeptidase)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Aspartate transaminase (AST)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Sodium	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Glucose	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Alanine transaminase (ALT)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Syndromes - Other	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Fever (in the absence of neutropenia)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Constipation	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Lymphopenia	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Leukocytes (total WBC)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Mucositis/stomatitis (functional/symptomatic)	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Insomnia	0 adverse events
HOD99 - Grade 5	Toxicities With Grade >1	Nausea	0 adverse events

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026

Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

3-year Event-Free Survival Probability

3-year Event-free Survival (EFS) Probability

3-year Local Failure-free Survival Probability

3-year Overall Survival (OS) Probability

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning

Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning

Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)

Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)

Disease Failure Rate Within Radiation Fields

Local and Distant Failure for Children Treated With Tailored-field Radiation

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning

Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score

Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems