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Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

This study has been terminated.
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00162695
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Rhabdomyosarcoma
Malignant Soft Tissue
 Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • To explore survival advantage for an intensified chemotherapy strategy in a randomised trial

Estimated Enrollment: 400
Study Start Date: July 1995
  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162695

Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Odile OBERLIN, Dr Institut Gustave Roussy
Principal Investigator: Michael STEVENS, Dr Hospital of Bristols, UK
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162695     History of Changes
Other Study ID Numbers: RMS95
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Rhabdomyosarcoma
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Etoposide
 Ifosfamide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013