Clinical trial · Interventional
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
NCT02245997CI-TRIAL-00095945completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiotherapy | Radiation | — | UNRESOLVED |
| proton beam RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patients with high-risk neuroblastoma
- 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).
- interventionNames
- Radiation: External beam radiotherapy
- Radiation: proton beam RT
Primary outcomes (1)
- measure
- assess local control rates treatment response
- timeFrame
- 3 yeas
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.