Sarcoma, Soft Tissue Clinical Trial
Official title:
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
Phase II Study to evaluate the response on two blocks of topotecan and carboplatin
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | March 2009 |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 21 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Zentralklinikum | Augsburg | |
| Germany | Klinikum Berlin-Buch | Berlin | |
| Germany | Virchow Klinik | Berlin | |
| Germany | Zentrum für Kinderheilkunde | Bonn | |
| Germany | Zentralkrankenhaus Bremen | Bremen | |
| Germany | Universitätsklinik der technischen Universität Dresden | Dresden | |
| Germany | Heinrich-Heine-Universität | Düsseldorf | |
| Germany | HELIOS Klinikum Erfurt GmbH | Erfurt | Sachsen |
| Germany | Universitätsklinik für Kinderund Jugendliche | Erlangen | |
| Germany | Universitätsklinikum Essen | Essen | |
| Germany | Klinikum der Universität | Frankfurt | |
| Germany | Universitäts-Kinderklinik Freiburg | Freiburg | |
| Germany | Klinikum der Justus-Liebig-Universität | Gießen | |
| Germany | Georg-August-Universität | Göttingen | |
| Germany | Universitäts-Kinderklinik Hamburg | Hamburg | |
| Germany | Kinderklinik der Medizinischen Hochschule | Hannover | |
| Germany | Universitäts-Kinderklinik | Heidelberg | |
| Germany | Universitäts-Kinderklinik | Homburg/saar | |
| Germany | Klinik für Kinder- und Jugendmedizin | Jena | |
| Germany | Städtisches Klinikum Karlruhe | Karlsruhe | |
| Germany | Klinikum der Universität Kiel | Kiel | |
| Germany | Klinikum der Stadt Köln | Köln | |
| Germany | Universitäts-Kinderklinik | Köln | |
| Germany | Universitätsklinik und Poliklinik | Leipzig | |
| Germany | Medizinische Universität zu Lübeck | Lübeck | |
| Germany | Kinderklinik St. Annastift | Ludwigshafen | |
| Germany | Medizinische Fakultät | Magdeburg | |
| Germany | Klinikum der Johannes-Gutenberg-Universität | Mainz | |
| Germany | Dr. von Haunersches Kinderspital | München | |
| Germany | Städtisches Krankenhaus Technische Universität Schwabing | München | |
| Germany | Westfälische Wilhelms-Universität | Münster | |
| Germany | Cnopf'sche Kinderklinik | Nürnberg | |
| Germany | Klinik St. Hedwig | Regensburg | |
| Germany | Johanniter-Kinderklinik | St.Augustin | |
| Germany | Olgahospital | Stuttgart | |
| Germany | Universitäts-Kinderklinik | Tübingen | |
| Germany | Universitäts-Kinderklinik | Ulm | |
| Germany | Universitäts-Kinderklinik | Würzburg |
| Lead Sponsor | Collaborator |
|---|---|
| Cooperative Weichteilsarkom Study Group | Deutsche Krebshilfe e.V., Bonn (Germany) |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response according to RECIST criteria | |||
| Secondary | Toxicity | |||
| Secondary | Overall-Survival | |||
| Secondary | Event-free-survival |
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