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a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

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.
 
ClinicalTrials.gov Identifier: NCT00130858
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : April 2, 2009
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
Cooperative Weichteilsarkom Study Group

Brief Summary:
Phase II Study to evaluate the response on two blocks of topotecan and carboplatin

Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Topotecan Drug: Carboplatin Phase 2

Detailed Description:
Phase II study for patients with chemosensible soft tissue sarcoma stage IV in children and adolescents ; response according to RECIST criteria following two blocks of combination therapy consisting of Topotecan and carboplatin

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
Study Start Date : January 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Topotecan




Primary Outcome Measures :
  1. Response according to RECIST criteria

Secondary Outcome Measures :
  1. Toxicity
  2. Overall-Survival
  3. Event-free-survival


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Soft tissue sarcoma chemosensible, stage IV
  • age < 21
  • measurable tumor lesions

Exclusion Criteria:

  • Lack of cooperation by the patient
  • no willingness of follow-up examinations
  • participation on another clinical trial at the same time
  • death due to the sickness within four weeks

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): NCT00130858


Locations
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Sponsors and Collaborators
Cooperative Weichteilsarkom Study Group
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
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Study Chair: Thomas Klingebiel, Prof. Dr. Klinikum der Johann Wolfgang Goethe-Universität

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ClinicalTrials.gov Identifier: NCT00130858    
Other Study ID Numbers: CWS-IV 2002
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: April 2, 2009
Last Verified: April 2009
Keywords provided by Cooperative Weichteilsarkom Study Group:
Sarcoma, Soft Tissue
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Carboplatin
Topotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action