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

Memorial Sloan Kettering Cancer Center1 site in 1 country78 target enrollmentSeptember 1, 2014

ConditionsNeuroblastoma

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Neuroblastoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 78
Locations: 1
Primary Endpoint: assess local control rates treatment response
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 1, 2014

End Date

May 1, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility 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 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:

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.

Outcomes

Primary Outcomes

assess local control rates treatment response

Time Frame: 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.