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

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

Study Overview

• Status: Completed
• Conditions: Neuroblastoma
• Intervention / Treatment: Radiation: External beam radiotherapy; Radiation: proton beam RT

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Radiation: External beam radiotherapy; Other Names: IMRT; Radiation: proton beam RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
event-free survival	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.	3 years
Assessment of toxicity	will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.	3 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Suzanne Wolden, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimated): September 22, 2014

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Reduced-dose Radiotherapy; 14-186
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neuroblastoma
• Other Study ID Numbers: 14-186