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CompletedNCT00130858Updated Apr 2, 2009

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

A Phase 2 interventional study of Topotecan and Carboplatin in Sarcoma, Soft Tissue, sponsored by Cooperative Weichteilsarkom Study Group. Completed at 38 sites in Germany. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2009-04-02.

Sponsored by Cooperative Weichteilsarkom Study Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
Up to 21 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Sarcoma, Soft Tissue

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Keywords

  • Sarcoma, Soft Tissue
03

In context

Sarcoma

1,668 studies on the registry are indexed under Sarcoma; 394 are open to participants now.

This study's planned enrollment of 90 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

This is the only study on the registry with Cooperative Weichteilsarkom Study Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Soft tissue sarcoma chemosensible, stage IV
  • age \< 21
  • measurable tumor lesions

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Interventions

  • DrugTopotecan
  • DrugCarboplatin
06

What researchers measure

Primary outcomes

  1. Response according to RECIST criteria

Secondary outcomes

  1. Toxicity

  2. Overall-Survival

  3. Event-free-survival

07

Study locations

38 sites
  • HELIOS Klinikum Erfurt GmbH
    Erfurt, Sachsen 99089, Germany
  • Zentralklinikum
    Augsburg, 86156, Germany
  • Klinikum Berlin-Buch
    Berlin, 13125, Germany
  • Virchow Klinik
    Berlin, 13353, Germany
  • Zentrum für Kinderheilkunde
    Bonn, 53113, Germany
  • Zentralkrankenhaus Bremen
    Bremen, 28205, Germany
  • Universitätsklinik der technischen Universität Dresden
    Dresden, 01307, Germany
  • Heinrich-Heine-Universität
    Düsseldorf, 40001, Germany
  • Universitätsklinik für Kinderund Jugendliche
    Erlangen, 91054, Germany
  • Universitätsklinikum Essen
    Essen, 45147, Germany
  • Klinikum der Universität
    Frankfurt, 60590, Germany
  • Universitäts-Kinderklinik Freiburg
    Freiburg, 79106, Germany
  • Klinikum der Justus-Liebig-Universität
    Gießen, 35392, Germany
  • Georg-August-Universität
    Göttingen, 37075, Germany
  • Universitäts-Kinderklinik Hamburg
    Hamburg, 20251, Germany
  • Kinderklinik der Medizinischen Hochschule
    Hannover, 30625, Germany
  • Universitäts-Kinderklinik
    Heidelberg, 69112, Germany
  • Universitäts-Kinderklinik
    Homburg/saar, 66421, Germany
  • Klinik für Kinder- und Jugendmedizin
    Jena, 07740, Germany
  • Städtisches Klinikum Karlruhe
    Karlsruhe, 76131, Germany
  • Klinikum der Universität Kiel
    Kiel, 24105, Germany
  • Klinikum der Stadt Köln
    Köln, 50735, Germany
  • Universitäts-Kinderklinik
    Köln, 50931, Germany
  • Universitätsklinik und Poliklinik
    Leipzig, 04137, Germany
  • Kinderklinik St. Annastift
    Ludwigshafen, 67067, Germany
  • Medizinische Universität zu Lübeck
    Lübeck, 25538, Germany
  • Medizinische Fakultät
    Magdeburg, 39120, Germany
  • Klinikum der Johannes-Gutenberg-Universität
    Mainz, 55101, Germany
  • Dr. von Haunersches Kinderspital
    München, 80337, Germany
  • Städtisches Krankenhaus Technische Universität Schwabing
    München, 80804, Germany
  • Westfälische Wilhelms-Universität
    Münster, 48149, Germany
  • Cnopf'sche Kinderklinik
    Nürnberg, 90419, Germany
  • Klinik St. Hedwig
    Regensburg, 93049, Germany
  • Johanniter-Kinderklinik
    St.Augustin, 53757, Germany
  • Olgahospital
    Stuttgart, 70176, Germany
  • Universitäts-Kinderklinik
    Tübingen, 72076, Germany
  • Universitäts-Kinderklinik
    Ulm, 89075, Germany
  • Universitäts-Kinderklinik
    Würzburg, 97080, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00130858
Lead sponsor
Cooperative Weichteilsarkom Study Group
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
First posted
Aug 16, 2005
Start date
Jan 2005
Primary completion
Dec 2007
Completion
Mar 2009
Last update
Apr 2, 2009

Study contacts

Thomas Klingebiel, Prof. Dr.
study chair · Klinikum der Johann Wolfgang Goethe-Universität
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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