drugset / Trial / NCT03165292
Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction
Phase 2
Terminated
34 enrolled
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.
Timeline
- Start
- 2018-10-01
- Primary completion
- 2023-08-28
- Completion
- 2024-03-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thiotepa | Other / unclassified | — | — |
| Subject | Topotecan | Small molecule | 0.7 mg/m2 | — |