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

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-08-15
• Study First Submitted QC: 2005-08-15
• Study First Posted: 2005-08-16
• Primary Completion: 2007-12
• Study Completion: 2009-03
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-01
• Last Update Posted: 2009-04-02

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

Name	Time	Method
Response according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Toxicity
Overall-Survival
Event-free-survival

Trial Locations

Locations (33)

Klinikum der Universität Kiel; 🇩🇪 Kiel, Germany

Zentralkrankenhaus Bremen; 🇩🇪 Bremen, Germany

Universitätsklinik der technischen Universität Dresden; 🇩🇪 Dresden, Germany

Heinrich-Heine-Universität; 🇩🇪 Düsseldorf, Germany

Kinderklinik der Medizinischen Hochschule; 🇩🇪 Hannover, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Klinik für Kinder- und Jugendmedizin; 🇩🇪 Jena, Germany

Klinikum der Stadt Köln; 🇩🇪 Köln, Germany

Klinikum der Universität; 🇩🇪 Frankfurt, Germany

Universitäts-Kinderklinik; 🇩🇪 Würzburg, Germany

Kinderklinik St. Annastift; 🇩🇪 Ludwigshafen, Germany

Medizinische Universität zu Lübeck; 🇩🇪 Lübeck, Germany

Dr. von Haunersches Kinderspital; 🇩🇪 München, Germany

Klinik St. Hedwig; 🇩🇪 Regensburg, Germany

Universitäts-Kinderklinik Freiburg; 🇩🇪 Freiburg, Germany

Cnopf'sche Kinderklinik; 🇩🇪 Nürnberg, Germany

Zentralklinikum; 🇩🇪 Augsburg, Germany

Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

Universitätsklinik für Kinderund Jugendliche; 🇩🇪 Erlangen, Germany

Städtisches Klinikum Karlruhe; 🇩🇪 Karlsruhe, Germany

Universitätsklinik und Poliklinik; 🇩🇪 Leipzig, Germany

Städtisches Krankenhaus Technische Universität Schwabing; 🇩🇪 München, Germany

Westfälische Wilhelms-Universität; 🇩🇪 Münster, Germany

HELIOS Klinikum Erfurt GmbH; 🇩🇪 Erfurt, Sachsen, Germany

Zentrum für Kinderheilkunde; 🇩🇪 Bonn, Germany

Klinikum der Justus-Liebig-Universität; 🇩🇪 Gießen, Germany

Virchow Klinik; 🇩🇪 Berlin, Germany

Universitäts-Kinderklinik Hamburg; 🇩🇪 Hamburg, Germany

Georg-August-Universität; 🇩🇪 Göttingen, Germany

Medizinische Fakultät; 🇩🇪 Magdeburg, Germany

Klinikum der Johannes-Gutenberg-Universität; 🇩🇪 Mainz, Germany

Olgahospital; 🇩🇪 Stuttgart, Germany

Johanniter-Kinderklinik; 🇩🇪 St.Augustin, Germany