Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Carboplatin; Epirubicin; Etoposide; Ifosfamide; Vincristine

Criteria

Inclusion Criteria:

• age > 6 months and < 18 years

• no distant metastases

• diagnosis within previous 8 weeks without prior treatment except surgery

• pathology available for central review

• written consent according to institutional requirement

Exclusion Criteria:

• stage III (node positive)

• stage I or II non alveolar orbital tumours

• patients with parameningeal disease aged < 3 years