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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00339118
First received: June 19, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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 Intervention Phase
Rhabdomyosarcoma
Drug: doxorubicin, cytoxan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • event free survival
  • overall survival

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00339118     History of Changes
Other Study ID Numbers: SHEBA-06-4013-IK-CTIL
Study First Received: June 19, 2006
Last Updated: June 19, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on August 01, 2014