Neuroblastoma
Conditions
Keywords
Reduced-dose Radiotherapy, 14-186
Brief summary
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
Interventions
RADIATIONExternal beam radiotherapy
RADIATIONproton beam RT
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have a diagnosis of neuroblastoma (International Classification of Disease for Oncology \[ICD-O\] morphology 9500/3) confirmed by MSKCC pathologic review * Patients must have high-risk neuroblastoma as defined by the COG Risk Stratification Schema o Patients with International agreement on staging (INSS) stage 4 are eligible with the following: * MYCN amplification, regardless of age or additional biologic features * Age \>18 months, regardless of biologic features OR * Age 1-18 months, with any of the 3 following unfavorable biologic OR features: MYCN amplification, unfavorable pathology, and/or DNA index = 1 o Patients with INSS stage 3 are eligible with the following: * MYCN amplification, regardless of age or additional biologic features OR * Age \> 18 months with unfavorable pathology, regardless of MYCN status o Patients with INSS stage 2a or 2b are eligible with the following: * MYCN amplification, regardless of age or additional biologic features o Patients with INSS stage 4s are eligible with the following: * MYCN amplification, regardless of additional biologic features Patients must have undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on trial. * Age at time of enrollment of ≥1 month and ≤18 years * Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start. * Female patients who are lactating must agree to stop breast-feeding. * Sexually active patients of childbearing potential must agree to use effective contraception.
Exclusion criteria
* Patients with gross residual tumor after surgical resection * Patients who have received prior radiotherapy at or adjacent to the primary tumor bed * Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess local control rates treatment response | 3 yeas | will be assessed via imaging (CT+/- MRI and MIBG) and clinical evidence at the primary site post completion of treatment. The baseline scan will be the pre-irradiation CT scan. Local failure is defined as a relapse in the primary tumor bed or adjacent lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| event-free survival | 3 years | will be performed for each patient using clinical data and imaging. Events are defined as failure (loco-regional and/or distant), treatment-related malignancy, or death. |
| Assessment of toxicity | 3 years | will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system. |
Countries
United States
Outcome results
None listed