drugset / Trial / NCT03042429
Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients
RandomizedSequentialOpen-labelTreatment
Summary
Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and consolidation therapy).
Timeline
- Start
- 2007-01-01
- Primary completion
- 2016-12-31
- Completion
- 2016-12-31
Outcome
Met primary endpoint
paper patients allocated megatherapy had increased 3-year event-free survival compared with those allocated maintenance therapy (47% [95% CI 38-55] vs 31% [95% CI 23-39]; PMID 16129365 ↗
paper hazard ratio 1.404 [95% CI 1.048-1.881], p=0.0221 PMID 16129365 ↗
Publications
- Results Berthold F, Hero B, Kremens B, Handgretinger R, Henze G, Schilling FH, Schrappe M, Simon T, Spix C. Long-term results and risk profiles of patients in five consecutive trials (1979-1997) with stage 4 neuroblastoma over 1 year of age. Cancer Lett. 2003 Jul 18;197(1-2):11-7. doi: 10.1016/s0304-3835(03)00076-4.
- Results Berthold F, Boos J, Burdach S, Erttmann R, Henze G, Hermann J, Klingebiel T, Kremens B, Schilling FH, Schrappe M, Simon T, Hero B. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment in patients with high-risk neuroblastoma: a randomised controlled trial. Lancet Oncol. 2005 Sep;6(9):649-58. doi: 10.1016/S1470-2045(05)70291-6.
- Results Langler A, Christaras A, Abshagen K, Krauth K, Hero B, Berthold F. Topotecan in the treatment of refractory neuroblastoma and other malignant tumors in childhood - a phase-II-study. Klin Padiatr. 2002 Jul-Aug;214(4):153-6. doi: 10.1055/s-2002-33175.
- Results Berthold F, Hero B. Neuroblastoma: current drug therapy recommendations as part of the total treatment approach. Drugs. 2000 Jun;59(6):1261-77. doi: 10.2165/00003495-200059060-00006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | — | — |
| Subject | Topotecan | Small molecule | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Comparator | Dacarbacine | Unknown | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Comparator | Ifosfamide | Small molecule | — | — |
| Comparator | Isotretinoin | Other / unclassified | — | — |
| Background | Melphalan | Small molecule | — | — |
| Comparator | Vindesine | Small molecule | — | — |