drugset / Trial / NCT04221035
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
RandomizedSequentialOpen-labelTreatment
Summary
This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.
Timeline
- Start
- 2019-11-05
- Primary completion
- 2026-11
- Completion
- 2032-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 0.8 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 0.95 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 1 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 1.1 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 1.2 mg/kg | Intravenous |
| Subject | Carboplatin | Small molecule | 750 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Dacarbazine | Small molecule | 200 mg/m2 | — |
| Subject | Dinutuximab | Monoclonal antibody | 0.33 mg/kg | — |
| Subject | Dinutuximab | Monoclonal antibody | 10 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Etoposide | Small molecule | 175 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 1500 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | — |
| Subject | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | — |
| Subject | Thiotepa | Other / unclassified | 300 mg/m2 | — |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | — |
| Subject | Vindesine | Small molecule | 3 mg/m2 | — |