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Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162695
First Posted: September 13, 2005
Last Update Posted: September 13, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162695


Locations
France
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
  More Information

ClinicalTrials.gov Identifier: NCT00162695     History of Changes
Other Study ID Numbers: RMS95
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: September 13, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Rhabdomyosarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Etoposide
Ifosfamide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents