Trials / Terminated
TerminatedNCT00162695
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (planned)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
- Sex
- All
- Age
- 6 Months – 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide |
Timeline
- Start date
- 1995-07-01
- First posted
- 2005-09-13
- Last updated
- 2005-09-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00162695. Inclusion in this directory is not an endorsement.