Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
- Registration Number
- NCT00876031
- Lead Sponsor
- University Hospital Tuebingen
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
-
written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
-
pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
-
Rhabdomyosarcoma of the "High Risk" Group, i.e.:
- RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
- RME, N1, M0, any IRS-group, any size or age
- RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
-
Rhabdomyosarcoma of the "Very High Risk" Group, i.e.:
- RMA, N1, MO, IRS II&III, any size or age or
- localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
- EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
- SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)
-
no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction; hypersensitivity)
-
no previous malignant tumours
-
available for long term follow up through the treating centre
-
in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
- pregnant or lactating women
- other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
- for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description O-TIE trofosfamide, idarubicin, etoposide oral maintenance therapy with trofosfamide, idarubicin, and etoposide
- Primary Outcome Measures
Name Time Method event free survival (EFS) 3 years
- Secondary Outcome Measures
Name Time Method Overall survival 5 years
Trial Locations
- Locations (55)
Medical Academy
🇵🇱Łódź, Poland
Gemeinschaftsklinikum Mayen-Koblenz
🇩🇪Koblenz, Germany
Helios Kliniken Schwerin
🇩🇪Schwerin, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
Klinikum Minden
🇩🇪Minden, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Kliniken der Stadt Köln
🇩🇪Köln, Germany
Krankenhaus München Schwabing
🇩🇪München, Germany
Cnopf'sche Kinderklinik
🇩🇪Nürnberg, Germany
Olgahospital
🇩🇪Stuttgart, Germany
Collegium Medicum
🇵🇱Bydgoszcz, Poland
Pian Medical University
🇵🇱Szczecin, Poland
Universitätskinderklinik beider Basel
🇨🇭Basel, Switzerland
Hopital Cantonal de Geneve
🇨🇭Geneve, Switzerland
Dr. von Haunersches Kinderspital
🇩🇪München, Germany
Mutterhaus der Borromäerinnen
🇩🇪Trier, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Asklepios Kinderklinik
🇩🇪Sankt Augustin, Germany
Krankenhaus der Stadt Dornbirn
🇦🇹Dornbirn, Austria
Universitätsklinik für Kinder- und Jugendheilkunde
🇦🇹Innsbruck, Austria
Landeskrankenhaus
🇦🇹Leoben, Austria
Landesfrauen - und Kinderklinik Linz
🇦🇹Linz, Austria
St. Johanns Spital / Landeskrankenhaus
🇦🇹Salzburg, Austria
St. Anna Kinderspital
🇦🇹Wien, Austria
Universitätsklinikum
🇩🇪Würzburg, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Charité
🇩🇪Berlin, Germany
Universitätskinderklinik
🇩🇪Düsseldorf, Germany
Krankenhaus Bielefeld
🇩🇪Bielefeld, Germany
Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Prof. Hess Kinderklinik
🇩🇪Bremen, Germany
Klinikum Chemnitz
🇩🇪Chemnitz, Germany
Vestische Kinderklinik
🇩🇪Datteln, Germany
Westfälisches Kinderzentrum, Klinikum Dortmund
🇩🇪Dortmund, Germany
Medizinische Hochschule
🇩🇪Hannover, Germany
Helios Klinikum
🇩🇪Erfurt, Germany
Gemeinschaftskrankenhaus Herdecke
🇩🇪Herdecke, Germany
Medical University
🇵🇱Wroclaw, Poland
Polish-American Institute of Paediatrics Jagiellonian University Medical College
🇵🇱Kraków, Poland
University Hospital, Dept. of Pediatrics
🇸🇪Linköping, Sweden
Department of Surgical Oncology for Children and Youth
🇵🇱Warszawa, Poland
Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital
🇸🇪Göteborg, 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
Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Inselspital University hospital
🇨🇭Bern, Switzerland
CHUV
🇨🇭Lausanne, Switzerland
Kinderspital
🇨🇭Luzern, Switzerland
Ostschweizer Kinderspital
🇨🇭Sankt Gallen, Switzerland
University Children's Hospital
🇨🇭Zurich, Switzerland
Silesian Medical Academy
🇵🇱Katowice, Poland