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Brief Title: Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
Official Title: A Randomised Phase-III Trial of the Cooperative Weichteilsarkom Study Group (CWS) for Localised High-risk Rhabdomyosarcoma and Localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in Children, Adolescents, and Young Adults
Study ID: NCT00876031
Brief Summary: The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma.
Detailed Description:
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Krankenhaus der Stadt Dornbirn, Dornbirn, , Austria
Universitätsklinik für Kinder- und Jugendheilkunde, Graz, , Austria
Universitätsklinik für Kinder- und Jugendheilkunde, Innsbruck, , Austria
Landeskrankenhaus, Klagenfurt, , Austria
Landeskrankenhaus, Leoben, , Austria
Landesfrauen - und Kinderklinik Linz, Linz, , Austria
St. Johanns Spital / Landeskrankenhaus, Salzburg, , Austria
St. Anna Kinderspital, Wien, , Austria
Universitätsklinikum, Aachen, , Germany
Klinikum Augsburg, Augsburg, , Germany
Charité, Berlin, , Germany
Helios Klinikum Berlin-Buch, Berlin, , Germany
Krankenhaus Bielefeld, Bielefeld, , Germany
Universitätskinderklinik, Bonn, , Germany
Klinikum Braunschweig, Braunschweig, , Germany
Prof. Hess Kinderklinik, Bremen, , Germany
Klinikum Chemnitz, Chemnitz, , Germany
Vestische Kinderklinik, Datteln, , Germany
Westfälisches Kinderzentrum, Klinikum Dortmund, Dortmund, , Germany
Universitätsklinikum, Dresden, , Germany
Universitätskinderklinik, Düsseldorf, , Germany
Helios Klinikum, Erfurt, , Germany
Universitätsklinikum, Erlangen, , Germany
Universitätsklinikum, Essen, , Germany
Universitätsklinikum, Frankfurt, , Germany
Universitätsklinikum, Freiburg, , Germany
Universitätsklinikum, Giessen, , Germany
Universitätsklinikum, Greifswald, , Germany
Universitätsklinikum, Göttingen, , Germany
Universitätsklinikum, Halle, , Germany
Universitätsklinikum, Hamburg, , Germany
Medizinische Hochschule, Hannover, , Germany
Universitätsklinikum, Heidelberg, , Germany
Gemeinschaftskrankenhaus Herdecke, Herdecke, , Germany
Universitätsklinikum, Homburg, , Germany
Universitätsklinikum, Jena, , Germany
Städtisches Klinikum Karlsruhe, Karlsruhe, , Germany
Klinikum Kassel, Kassel, , Germany
Universitätsklinikum, Kiel, , Germany
Gemeinschaftsklinikum Mayen-Koblenz, Koblenz, , Germany
Kliniken der Stadt Köln, Köln, , Germany
Universitätsklinikum, Köln, , Germany
Universitätsklinikum, Leipzig, , Germany
Universitätsklinikum, Lübeck, , Germany
Universitätsklinikum, Magdeburg, , Germany
Universitätsklinikum, Mainz, , Germany
Universitätsklinikum, Mannheim, , Germany
Klinikum Minden, Minden, , Germany
Dr. von Haunersches Kinderspital, München, , Germany
Krankenhaus München Schwabing, München, , Germany
Universitätsklinikum, Münster, , Germany
Cnopf'sche Kinderklinik, Nürnberg, , Germany
Klinikum Oldenburg, Oldenburg, , Germany
Universitätsklinikum, Regensburg, , Germany
Universitätsklinikum, Rostock, , Germany
Asklepios Kinderklinik, Sankt Augustin, , Germany
Helios Kliniken Schwerin, Schwerin, , Germany
Olgahospital, Stuttgart, , Germany
Mutterhaus der Borromäerinnen, Trier, , Germany
Universitätsklinikum, Tübingen, , Germany
Universitätsklinikum, Ulm, , Germany
Universitätsklinikum, Würzburg, , Germany
Medical University, Białystok, , Poland
Collegium Medicum, Bydgoszcz, , Poland
Medical Academy, Gdansk, , Poland
Silesian Medical Academy, Katowice, , Poland
Polish-American Institute of Paediatrics Jagiellonian University Medical College, Kraków, , Poland
Medical Academy, Lublin, , Poland
Pian Medical University, Szczecin, , Poland
Department of Surgical Oncology for Children and Youth, Warszawa, , Poland
Medical University, Wroclaw, , Poland
Medical Academy, Łódź, , Poland
Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital, Göteborg, , Sweden
University Hospital, Dept. of Pediatrics, Linköping, , Sweden
University Hospital, Dept. of Pediatric Hematology and Oncology, Lund, , Sweden
Karolinska University Hospital, Astrid Lindgrens Children's Hospital, Stockholm, , Sweden
Norrland's University Hospital, Dept. of Pediatrics, Umea, , Sweden
Children's University Hospital, Uppsala, , Sweden
Kantonsspital, Aarau, , Switzerland
Universitätskinderklinik beider Basel, Basel, , Switzerland
Ospedale San Giovanni, Bellinzona, , Switzerland
Inselspital University hospital, Bern, , Switzerland
Hopital Cantonal de Geneve, Geneve, , Switzerland
CHUV, Lausanne, , Switzerland
Kinderspital, Luzern, , Switzerland
Ostschweizer Kinderspital, Sankt Gallen, , Switzerland
University Children's Hospital, Zurich, , Switzerland
Name: Ewa Koscielniak, MD
Affiliation: Olgahospital, CWS
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Klingebiel, MD
Affiliation: Universitätsklinikum Frankfurt, CWS
Role: STUDY_CHAIR
Name: Monika Sparber Sauer, MD
Affiliation: Olgahospital, CWS
Role: STUDY_DIRECTOR