New York, New York 10065


Purpose:

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


Criteria:

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 12-18 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 year 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.


NCT ID:

NCT02245997


Primary Contact:

Principal Investigator
Suzanne Wolden, MD
Memorial Sloan Kettering Cancer Center

Suzanne Wolden, MD
Phone: 212-639-5148


Backup Contact:

Brian Kushner, MD
Phone: 212-639-6793


Location Contact:

New York, New York 10065
United States

Suzanne Wolden, MD
Phone: 212-639-5148

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.