drugset / Trial / NCT00162695

Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

NCT00162695

Phase 3 Terminated 400 enrolled Gustave Roussy, Cancer Campus, Grand Paris
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

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Epirubicin Small molecule
Subject Etoposide Small molecule
Background Ifosfamide Small molecule
Background Vincristine Small molecule
Background actinomycine D Unknown

Indications