Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Gustave Roussy

Status and phase: Terminated; Phase 3

Conditions: Rhabdomyosarcoma; Malignant Soft Tissue

Treatments: Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT00162695

RMS95

Details and patient eligibility

About

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.

Sex: All

Ages: 6 months to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)