Status:
COMPLETED
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Neuroblastoma
Eligibility:
All Genders
12-18 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT02245997
Start Date
September 1 2014
End Date
May 1 2025
Last Update
September 29 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065