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NCT00162695 Clinical Trial

Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Rhabdomyosarcoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00162695
Other study ID # RMS95
Secondary ID
Status Terminated
Phase Phase 3
First received September 9, 2005
Last updated September 9, 2005
Start date July 1995

Study information
Verified date September 2005
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 21 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
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