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

NCT ID: NCT02245997

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2025-05-01

Brief Summary

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

Conditions

Neuroblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with high-risk neuroblastoma

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).

Group Type: EXPERIMENTAL

External beam radiotherapy

Intervention Type: RADIATION

proton beam RT

Intervention Type: RADIATION

Interventions

External beam radiotherapy

Intervention Type: RADIATION

proton beam RT

Intervention Type: RADIATION

Other Intervention Names

IMRT

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:

• 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne Wolden, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-186

Identifier Type: -

Identifier Source: org_study_id