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

April 1, 2009 updated by: Cooperative Weichteilsarkom Study Group
Phase II Study to evaluate the response on two blocks of topotecan and carboplatin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86156
        • Zentralklinikum
      • Berlin, Germany, 13125
        • Klinikum Berlin-Buch
      • Berlin, Germany, 13353
        • Virchow Klinik
      • Bonn, Germany, 53113
        • Zentrum für Kinderheilkunde
      • Bremen, Germany, 28205
        • Zentralkrankenhaus Bremen
      • Dresden, Germany, 01307
        • Universitätsklinik der technischen Universität Dresden
      • Düsseldorf, Germany, 40001
        • Heinrich-Heine-Universität
      • Erlangen, Germany, 91054
        • Universitätsklinik für Kinderund Jugendliche
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Frankfurt, Germany, 60590
        • Klinikum der Universität
      • Freiburg, Germany, 79106
        • Universitäts-Kinderklinik Freiburg
      • Gießen, Germany, 35392
        • Klinikum der Justus-Liebig-Universität
      • Göttingen, Germany, 37075
        • Georg-August-Universität
      • Hamburg, Germany, 20251
        • Universitäts-Kinderklinik Hamburg
      • Hannover, Germany, 30625
        • Kinderklinik der Medizinischen Hochschule
      • Heidelberg, Germany, 69112
        • Universitäts-Kinderklinik
      • Homburg/saar, Germany, 66421
        • Universitäts-Kinderklinik
      • Jena, Germany, 07740
        • Klinik für Kinder- und Jugendmedizin
      • Karlsruhe, Germany, 76131
        • Städtisches Klinikum Karlruhe
      • Kiel, Germany, 24105
        • Klinikum der Universität Kiel
      • Köln, Germany, 50735
        • Klinikum der Stadt Köln
      • Köln, Germany, 50931
        • Universitäts-Kinderklinik
      • Leipzig, Germany, 04137
        • Universitätsklinik und Poliklinik
      • Ludwigshafen, Germany, 67067
        • Kinderklinik St. Annastift
      • Lübeck, Germany, 25538
        • Medizinische Universität zu Lübeck
      • Magdeburg, Germany, 39120
        • Medizinische Fakultät
      • Mainz, Germany, 55101
        • Klinikum der Johannes-Gutenberg-Universität
      • München, Germany, 80337
        • Dr. von Haunersches Kinderspital
      • München, Germany, 80804
        • Städtisches Krankenhaus Technische Universität Schwabing
      • Münster, Germany, 48149
        • Westfälische Wilhelms-Universität
      • Nürnberg, Germany, 90419
        • Cnopf'sche Kinderklinik
      • Regensburg, Germany, 93049
        • Klinik St. Hedwig
      • St.Augustin, Germany, 53757
        • Johanniter-Kinderklinik
      • Stuttgart, Germany, 70176
        • Olgahospital
      • Tübingen, Germany, 72076
        • Universitäts-Kinderklinik
      • Ulm, Germany, 89075
        • Universitäts-Kinderklinik
      • Würzburg, Germany, 97080
        • Universitäts-Kinderklinik
    • Sachsen
      • Erfurt, Sachsen, Germany, 99089
        • Helios Klinikum Erfurt GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response according to RECIST criteria

Secondary Outcome Measures

Outcome Measure
Toxicity
Event-free-survival
Overall-Survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cooperative Weichteilsarkom Study Group

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

  • Study Chair: Thomas Klingebiel, Prof. Dr., Klinikum der Johann Wolfgang Goethe-Universität

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 15, 2005

First Submitted That Met QC Criteria

August 15, 2005

First Posted (Estimate)

August 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 2, 2009

Last Update Submitted That Met QC Criteria

April 1, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWS-IV 2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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