Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
Phase 3
Terminated
- Conditions
- RhabdomyosarcomaMalignant Soft Tissue
- Registration Number
- NCT00162695
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 400
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
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Exclusion Criteria
- stage III (node positive)
- stage I or II non alveolar orbital tumours
- patients with parameningeal disease aged < 3 years
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, France