drugset / Trial / NCT00162695
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
RandomizedParallel-groupOpen-labelTreatment
Summary
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial. IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery. The study was powered to detect 10% difference in 3 year OS.
Timeline
- Start
- 1995-07
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Epirubicin | Small molecule | — | — |
| Subject | Etoposide | Small molecule | — | — |
| Background | Ifosfamide | Small molecule | — | — |
| Background | Vincristine | Small molecule | — | — |
| Background | actinomycine D | Unknown | — | — |