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

Phase 2
Completed
Conditions
Sarcoma, Soft Tissue
Registration Number
NCT00130858
Lead Sponsor
Cooperative Weichteilsarkom Study Group
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Response according to RECIST criteria
Secondary Outcome Measures
NameTimeMethod
Toxicity
Overall-Survival
Event-free-survival

Trial Locations

Locations (33)

HELIOS Klinikum Erfurt GmbH

🇩🇪

Erfurt, Sachsen, Germany

Zentralklinikum

🇩🇪

Augsburg, Germany

Klinikum Berlin-Buch

🇩🇪

Berlin, Germany

Virchow Klinik

🇩🇪

Berlin, Germany

Zentrum für Kinderheilkunde

🇩🇪

Bonn, Germany

Zentralkrankenhaus Bremen

🇩🇪

Bremen, Germany

Universitätsklinik der technischen Universität Dresden

🇩🇪

Dresden, Germany

Heinrich-Heine-Universität

🇩🇪

Düsseldorf, Germany

Universitätsklinik für Kinderund Jugendliche

🇩🇪

Erlangen, Germany

Universitätsklinikum Essen

🇩🇪

Essen, Germany

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HELIOS Klinikum Erfurt GmbH
🇩🇪Erfurt, Sachsen, Germany

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