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Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

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ClinicalTrials.gov Identifier: NCT00162695
Recruitment Status : Terminated
First Posted : September 13, 2005
Last Update Posted : September 13, 2005
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 1995

Resource links provided by the National Library of Medicine





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


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

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
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France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
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Principal Investigator: Odile OBERLIN, Dr Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Michael STEVENS, Dr Hospital of Bristols, UK
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ClinicalTrials.gov Identifier: NCT00162695    
Other Study ID Numbers: RMS95
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: September 13, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Rhabdomyosarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Etoposide
Vincristine
Epirubicin
Ifosfamide
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic