Uterine Cervical Neoplasms
Conditions
Keywords
Positron-Emission Tomography, Radiotherapy, Intensity-Modulated
Brief summary
Our primary hypothesis is that \[18F\]FLT PET can identify active bone marrow in addition to metabolically active tumor. This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.
Detailed description
Subjects will undergo a total of up to 5 FLT PET scans. Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan. Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy. Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.
Interventions
DRUG[F18]Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)
Sponsors
Holden Comprehensive Cancer Center
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand and willingness to sign a written informed consent document. * Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix. * Scheduled to receive chemo-radiation for oncologic treatment. * Karnofsky of at least 60 at time of screening * Life expectancy of at least 6 months. * Leukocytes at least 3,000/microL * absolute neutrophil count at least 1,500/microL * platelets at least 100,000/microL * total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal) * either ALT or AST less than 2.5 times the upper limit of normal * creatinine less than 1.5 times the upper limit of normal * non-pregnant, non-nursing, willing to use contraception
Exclusion criteria
* oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. * subjects taking nucleoside analog medications such as those used as antiretroviral agents. * patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Difference From Baseline IMRT Plan (%) | Baseline (pre-treatment) | The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation dose bins evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy Compliance | post-treatment | The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts. |
| Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment | White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment | Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment | Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up. |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment | Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%) | 4 |
| Group 2 Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
\[F18\]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%) | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
Percent Difference From Baseline IMRT Plan (%)
The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation dose bins evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.
Time frame: Baseline (pre-treatment)
Population: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 5 Gray | -8.5 Percent difference (%) | Standard Deviation 6 |
| All Participants | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 10 Gray | -11.7 Percent difference (%) | Standard Deviation 7.3 |
| All Participants | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 20 Gray | -15.8 Percent difference (%) | Standard Deviation 3.8 |
| All Participants | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 30 Gray | -16.5 Percent difference (%) | Standard Deviation 12.6 |
| All Participants | Percent Difference From Baseline IMRT Plan (%) | % difference, dose to target (tumor) volume | -0.2 Percent difference (%) | Standard Deviation 0.1 |
Secondary
Chemotherapy Compliance
The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.
Time frame: post-treatment
Population: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Chemotherapy Compliance | Received all chemotherapy as precscribed | 4 Participants |
| All Participants | Chemotherapy Compliance | Missed 1 cycle of chemotherapy | 1 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up.
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Population: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 0 (no toxicity) | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 1 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 0 (no toxicity) | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 1 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 0 (no toxicity) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | Not assessed (test omitted) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 0 (no toxicity) | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 1 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | Not assessed (test omitted) | 3 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Population: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 0 (no toxicity) | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 1 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 0 (no toxicity) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 4 (most severe) | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | Not assessed (test omitted) | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 0 (no toxicity) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 1 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 2 | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 3 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 4 (most severe) | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 0 (no toxicity) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 3 | 4 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 3 | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 0 (no toxicity) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 2 | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 3 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | Not assessed (test omitted) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 0 (no toxicity) | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 3 | 0 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Population: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 0 (no toxicity) | 4 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 1 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 0 (no toxicity) | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 1 | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 0 (no toxicity) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 1 | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 0 (no toxicity) | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 1 | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | Not assessed (test omitted) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 0 (no toxicity) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | Not assessed (test omitted) | 3 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Population: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 0 (no toxicity) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | Not assessed (test omitted) | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | Not assessed (test omitted) | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 0 (no toxicity) | 5 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 0 (no toxicity) | 4 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 1 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 2 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 0 (no toxicity) | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 2 | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 0 (no toxicity) | 3 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 2 | 2 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | Not assessed (test omitted) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 3 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 4 (most severe) | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 0 (no toxicity) | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 1 | 0 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 2 | 1 Participants |
| All Participants | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 3 | 0 Participants |