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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130858
First Posted: August 16, 2005
Last Update Posted: April 2, 2009
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.
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
Cooperative Weichteilsarkom Study Group
August 15, 2005
August 16, 2005
April 2, 2009
January 2005
December 2007   (Final data collection date for primary outcome measure)
Response according to RECIST criteria
Same as current
Complete list of historical versions of study NCT00130858 on ClinicalTrials.gov Archive Site
  • Toxicity
  • Overall-Survival
  • Event-free-survival
Same as current
Not Provided
Not Provided
 
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
Phase II Study to evaluate the response on two blocks of topotecan and carboplatin
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
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sarcoma, Soft Tissue
  • Drug: Topotecan
  • Drug: Carboplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
March 2009
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00130858
CWS-IV 2002
Not Provided
Not Provided
Not Provided
Not Provided
Cooperative Weichteilsarkom Study Group
Deutsche Krebshilfe e.V., Bonn (Germany)
Study Chair: Thomas Klingebiel, Prof. Dr. Klinikum der Johann Wolfgang Goethe-Universität
Cooperative Weichteilsarkom Study Group
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP