a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
This study has been completed.
Sponsor:
Cooperative Weichteilsarkom Study Group
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
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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) |
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
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 May 19, 2013