Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
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.
|Rhabdomyosarcoma Malignant Soft Tissue||Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162695
|Institut Gustave Roussy|
|Villejuif, France, 94800|
|Principal Investigator:||Odile OBERLIN, Dr||Gustave Roussy, Cancer Campus, Grand Paris|
|Principal Investigator:||Michael STEVENS, Dr||Hospital of Bristols, UK|