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EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children

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ClinicalTrials.gov Identifier: NCT00339118
Recruitment Status : Unknown
Verified June 2006 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2006
Last Update Posted : June 20, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase.

Condition or disease Intervention/treatment Phase
Rhabdomyosarcoma Drug: doxorubicin, cytoxan Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by the National Library of Medicine

Drug Information available for: Doxorubicin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. event free survival
  2. overall survival

Eligibility Criteria

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:

  • child
  • non metastatic rhabdomyosarcoma
  • adequate heart, kidney, liver function

Exclusion Criteria:

  • age over 21 years, under 6 months
  • metastatic disease
  • heart, kidney, liver disease
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): NCT00339118


Contacts
Contact: Iris Kventsel, MD 97235303037 iris.kventsel@sheba.health.gov.il

Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Iris Kventsel, MD Sheba Medical Center
More Information

ClinicalTrials.gov Identifier: NCT00339118     History of Changes
Other Study ID Numbers: SHEBA-06-4013-IK-CTIL
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: June 20, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
Rhabdomyosarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Doxorubicin
Cyclophosphamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists