Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma

Study Overview
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Brief Summary
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The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.

Official Title
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Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma

Conditions
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Neuroblastoma

Intervention / Treatment
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* Radiation: External beam radiotherapy
* Radiation: proton beam RT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with high-risk neuroblastoma<br>Patients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments). Patients will be evaluated by physical exams, CT scan or MRI of the primary site, and MIBG at, 6, 12, 18 and 24 months (+/- 6 weeks). | Radiation: External beam radiotherapy<br> <br> * Other names: IMRT;Radiation: proton beam RT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess local control rates treatment response | 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. | 3 yeas | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event-free survival | 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. | 3 years | 
| Assessment of toxicity | will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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14-186, Reduced-dose Radiotherapy