Trial Information
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
Principal Investigator
Odile OBERLIN, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
RMS95
NCT ID:
NCT00162695
Start Date:
July 1995
Completion Date:
Related Keywords:
- Rhabdomyosarcoma
- Malignant Soft Tissue
- Rhabdomyosarcoma
- Sarcoma