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Clinical Trials/NCT00130858
NCT00130858
Completed
Phase 2

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

Cooperative Weichteilsarkom Study Group33 sites in 1 country90 target enrollmentJanuary 2005
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ConditionsSarcoma, Soft Tissue
DrugsTopotecanCarboplatin

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Sarcoma, Soft Tissue
Sponsor
Cooperative Weichteilsarkom Study Group
Enrollment
90
Locations
33
Primary Endpoint
Response according to RECIST criteria
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
March 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cooperative Weichteilsarkom Study Group

Eligibility 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

Outcomes

Primary Outcomes

Response according to RECIST criteria

Secondary Outcomes

  • Toxicity
  • Overall-Survival
  • Event-free-survival

Study Sites (33)

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