Clinical Trial: Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title:

Brief 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.

Detailed Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: To explore survival advantage for an intensified chemotherapy strategy in a randomised trial

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: September 9, 2005
Date Started: July 1995
Date Completion:
Last Updated: September 9, 2005
Last Verified: September 2005