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

This study has been completed.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
Cooperative Weichteilsarkom Study Group
ClinicalTrials.gov Identifier:
NCT00130858
First received: August 15, 2005
Last updated: April 1, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Sarcoma, Soft Tissue
Drug: Topotecan
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

Resource links provided by NLM:


Further study details as provided by Cooperative Weichteilsarkom Study Group:

Primary Outcome Measures:
  • Response according to RECIST criteria

Secondary Outcome Measures:
  • Toxicity
  • Overall-Survival
  • Event-free-survival

Estimated Enrollment: 90
Study Start Date: January 2005
Study Completion Date: March 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130858

Locations
Germany
HELIOS Klinikum Erfurt GmbH
Erfurt, Sachsen, Germany, 99089
Zentralklinikum
Augsburg, Germany, 86156
Virchow Klinik
Berlin, Germany, 13353
Klinikum Berlin-Buch
Berlin, Germany, 13125
Zentrum für Kinderheilkunde
Bonn, Germany, 53113
Zentralkrankenhaus Bremen
Bremen, Germany, 28205
Universitätsklinik der technischen Universität Dresden
Dresden, Germany, 01307
Heinrich-Heine-Universität
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
Georg-August-Universität
Göttingen, Germany, 37075
Universitäts-Kinderklinik Hamburg
Hamburg, Germany, 20251
Kinderklinik der Medizinischen Hochschule
Hannover, Germany, 30625
Universitäts-Kinderklinik
Heidelberg, Germany, 69112
Universitäts-Kinderklinik
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
Universitäts-Kinderklinik
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
Johanniter-Kinderklinik
St.Augustin, Germany, 53757
Olgahospital
Stuttgart, Germany, 70176
Universitäts-Kinderklinik
Tübingen, Germany, 72076
Universitäts-Kinderklinik
Ulm, Germany, 89075
Universitäts-Kinderklinik
Würzburg, Germany, 97080
Sponsors and Collaborators
Cooperative Weichteilsarkom Study Group
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Study Chair: Thomas Klingebiel, Prof. Dr. Klinikum der Johann Wolfgang Goethe-Universität
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130858     History of Changes
Other Study ID Numbers: CWS-IV 2002
Study First Received: August 15, 2005
Last Updated: April 1, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cooperative Weichteilsarkom Study Group:
Sarcoma, Soft Tissue

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Carboplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014