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

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 75

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with high-risk neuroblastoma	proton beam RT	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).
patients with high-risk neuroblastoma	External beam radiotherapy	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assessment of toxicity	3 years	will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.
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.

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

Recruitment & Eligibility

Study & Design

Trial Locations

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