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

Not Applicable

Completed

• Conditions: Neuroblastoma

• Registration Number: NCT02245997
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States