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

NCT02245997 | Completed Early Phase 1

• 1 other identifier: 14-186
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

Reduced-dose Radiotherapy; 14-186

Outcome Measures

Primary Outcomes (1)

• assess local control rates treatment response

  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.

  3 yeas

Secondary Outcomes (2)

• event-free survival

  3 years

• Assessment of toxicity

  3 years

Study Arms (1)

patients with high-risk neuroblastoma

EXPERIMENTAL

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).

Radiation: External beam radiotherapy; Radiation: proton beam RT

Interventions

External beam radiotherapy RADIATION

Also known as: IMRT

patients with high-risk neuroblastoma

proton beam RT RADIATION

patients with high-risk neuroblastoma

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Suzanne Wolden, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 22, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-07

Locations

US (1)