NCT02245997CompletedEarly phase 1
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 17 Sept 2014
- Start date
- 1 Sept 2014
- Primary completion date
- 1 May 2025
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT02245997
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 78
- From 1 Sept 2014 to the primary completion date, 1 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.