Soft Tissue Sarcoma Clinical Trial
— CWS-2007-HROfficial 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
| Verified date | November 2022 |
| Source | University Hospital Tuebingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 195 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | June 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 21 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| Austria | 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 | |
| Germany | 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 | Göttingen | |
| Germany | Universitätsklinikum | Greifswald | |
| 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 | |
| Poland | Medical University | Bialystok | |
| 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 | Lódz | |
| Poland | Medical Academy | Lublin | |
| Poland | Pian Medical University | Szczecin | |
| Poland | Department of Surgical Oncology for Children and Youth | Warszawa | |
| Poland | Medical University | Wroclaw | |
| Sweden | 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 | |
| Switzerland | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen | Cooperative Weichteilsarkom Study Group, Deutsche Kinderkrebsstiftung, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany, Polish Paediatric Solid Tumours Study Group, Swiss Pediatric Oncology Group, The Swedish Childhood Solid Tumor Working Group |
Austria, Germany, Poland, Sweden, Switzerland,
Dantonello TM, Int-Veen C, Harms D, Leuschner I, Schmidt BF, Herbst M, Juergens H, Scheel-Walter HG, Bielack SS, Klingebiel T, Dickerhoff R, Kirsch S, Brecht I, Schmelzle R, Greulich M, Gadner H, Greiner J, Marky I, Treuner J, Koscielniak E. Cooperative trial CWS-91 for localized soft tissue sarcoma in children, adolescents, and young adults. J Clin Oncol. 2009 Mar 20;27(9):1446-55. doi: 10.1200/JCO.2007.15.0466. Epub 2009 Feb 17. — View Citation
Dantonello TM, Int-Veen C, Winkler P, Leuschner I, Schuck A, Schmidt BF, Lochbuehler H, Kirsch S, Hallmen E, Veit-Friedrich I, Bielack SS, Niggli F, Kazanowska B, Ladenstein R, Wiebe T, Klingebiel T, Treuner J, Koscielniak E. Initial patient characteristics can predict pattern and risk of relapse in localized rhabdomyosarcoma. J Clin Oncol. 2008 Jan 20;26(3):406-13. doi: 10.1200/JCO.2007.12.2382. Erratum in: J Clin Oncol.2008 Apr 10;26(11) 1911. — View Citation
Dantonello TM, Winkler P, Boelling T, Friedel G, Schmid I, Mattke AC, Ljungman G, Bielack SS, Klingebiel T, Koscielniak E; CWS Study Group. Embryonal rhabdomyosarcoma with metastases confined to the lungs: report from the CWS Study Group. Pediatr Blood Cancer. 2011 May;56(5):725-32. doi: 10.1002/pbc.22862. Epub 2010 Nov 8. — View Citation
Klingebiel T, Boos J, Beske F, Hallmen E, Int-Veen C, Dantonello T, Treuner J, Gadner H, Marky I, Kazanowska B, Koscielniak E. Treatment of children with metastatic soft tissue sarcoma with oral maintenance compared to high dose chemotherapy: report of th — View Citation
Koscielniak E, Morgan M, Treuner J. Soft tissue sarcoma in children: prognosis and management. Paediatr Drugs. 2002;4(1):21-8. — View Citation
Mattke AC, Bailey EJ, Schuck A, Dantonello T, Leuschner I, Klingebiel T, Treuner J, Koscielniak E. Does the time-point of relapse influence outcome in pediatric rhabdomyosarcomas? Pediatr Blood Cancer. 2009 Jul;52(7):772-6. doi: 10.1002/pbc.21906. — View Citation
Siepermann M, Koscielniak E, Dantonello T, Klee D, Boos J, Krefeld B, Borkhardt A, Hoehn T, Asea A, Wessalowski R. Oral low-dose chemotherapy: successful treatment of an alveolar rhabdomyosarcoma during pregnancy. Pediatr Blood Cancer. 2012 Jan;58(1):104-6. doi: 10.1002/pbc.22934. Epub 2011 Jan 16. — View Citation
Weihkopf T, Blettner M, Dantonello T, Jung I, Klingebiel T, Koscielniak E, Lückel M, Spix C, Kaatsch P. Incidence and time trends of soft tissue sarcomas in German children 1985-2004 - a report from the population-based German Childhood Cancer Registry. Eur J Cancer. 2008 Feb;44(3):432-40. — View Citation
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|---|---|---|---|---|
| Primary | event free survival (EFS) | 3 years | ||
| Secondary | Overall survival | 5 years |
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