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. Identifier: NCT00130858
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : April 2, 2009
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

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

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 identifier (NCT number): NCT00130858

HELIOS Klinikum Erfurt GmbH
Erfurt, Sachsen, Germany, 99089
Augsburg, Germany, 86156
Klinikum Berlin-Buch
Berlin, Germany, 13125
Virchow Klinik
Berlin, Germany, 13353
Zentrum für Kinderheilkunde
Bonn, Germany, 53113
Zentralkrankenhaus Bremen
Bremen, Germany, 28205
Universitätsklinik der technischen Universität Dresden
Dresden, Germany, 01307
Düsseldorf, Germany, 40001
Universitätsklinik für Kinderund Jugendliche
Erlangen, Germany, 91054
Universitätsklinikum Essen
Essen, Germany, 45147
Klinikum der Universität
Frankfurt, Germany, 60590
Universitäts-Kinderklinik Freiburg
Freiburg, Germany, 79106
Klinikum der Justus-Liebig-Universität
Gießen, Germany, 35392
Göttingen, Germany, 37075
Universitäts-Kinderklinik Hamburg
Hamburg, Germany, 20251
Kinderklinik der Medizinischen Hochschule
Hannover, Germany, 30625
Heidelberg, Germany, 69112
Homburg/saar, Germany, 66421
Klinik für Kinder- und Jugendmedizin
Jena, Germany, 07740
Städtisches Klinikum Karlruhe
Karlsruhe, Germany, 76131
Klinikum der Universität Kiel
Kiel, Germany, 24105
Klinikum der Stadt Köln
Köln, Germany, 50735
Köln, Germany, 50931
Universitätsklinik und Poliklinik
Leipzig, Germany, 04137
Kinderklinik St. Annastift
Ludwigshafen, Germany, 67067
Medizinische Universität zu Lübeck
Lübeck, Germany, 25538
Medizinische Fakultät
Magdeburg, Germany, 39120
Klinikum der Johannes-Gutenberg-Universität
Mainz, Germany, 55101
Dr. von Haunersches Kinderspital
München, Germany, 80337
Städtisches Krankenhaus Technische Universität Schwabing
München, Germany, 80804
Westfälische Wilhelms-Universität
Münster, Germany, 48149
Cnopf'sche Kinderklinik
Nürnberg, Germany, 90419
Klinik St. Hedwig
Regensburg, Germany, 93049
St.Augustin, Germany, 53757
Stuttgart, Germany, 70176
Tübingen, Germany, 72076
Ulm, Germany, 89075
Würzburg, Germany, 97080
Sponsors and Collaborators
Cooperative Weichteilsarkom Study Group
Deutsche Krebshilfe e.V., Bonn (Germany)
Study Chair: Thomas Klingebiel, Prof. Dr. Klinikum der Johann Wolfgang Goethe-Universität Identifier: NCT00130858     History of Changes
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:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action