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Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

This study has been terminated.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Estimated Enrollment: 400
Study Start Date: July 1995

Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
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
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Please refer to this study by its identifier: NCT00162695

Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Odile OBERLIN, Dr Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Michael STEVENS, Dr Hospital of Bristols, UK
  More Information Identifier: NCT00162695     History of Changes
Other Study ID Numbers: RMS95
Study First Received: September 9, 2005
Last Updated: September 9, 2005

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents processed this record on June 23, 2017