Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00162695
• Collaborator: (none)
• Enrollment: 400
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhabdomyosarcoma; Malignant Soft Tissue	Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 1995

Outcome Measures

Primary Outcome Measures

1. To explore survival advantage for an intensified chemotherapy strategy in a randomised trial []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif		France	94800

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

• Principal Investigator: Odile OBERLIN, Dr, Gustave Roussy, Cancer Campus, Grand Paris
• Principal Investigator: Michael STEVENS, Dr, Hospital of Bristols, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00162695
• Other Study ID Numbers: RMS95
• First Posted: Sep 13, 2005
• Last Update Posted: Sep 13, 2005
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Rhabdomyosarcoma; Etoposide; Vincristine; Epirubicin; Ifosfamide; Carboplatin

Study Results

No Results Posted as of Sep 13, 2005