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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Early Phase 1

Conditions: Neuroblastoma

Treatments: Radiation: External beam radiotherapy; Radiation: proton beam RT

Study type: Interventional

Funder types: Other

Identifiers

NCT02245997

14-186

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 12 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

patients with high-risk neuroblastoma

Experimental group

Description:

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).

Treatment:

Radiation: proton beam RT

Radiation: External beam radiotherapy