Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
CWS-2007-HR
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
6 other identifiers
interventional
195
5 countries
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2009
Longer than P75 for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 8, 2022
November 1, 2022
13 years
April 2, 2009
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
event free survival (EFS)
3 years
Secondary Outcomes (1)
Overall survival
5 years
Study Arms (2)
O-TIE
EXPERIMENTALoral maintenance therapy with trofosfamide, idarubicin, and etoposide
control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingenlead
- Cooperative Weichteilsarkom Study Groupcollaborator
- Deutsche Kinderkrebsstiftungcollaborator
- German Society for Pediatric Oncology and Hematology GPOH gGmbHcollaborator
- Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austriacollaborator
- The Swedish Childhood Solid Tumor Working Groupcollaborator
- Polish Paediatric Solid Tumours Study Groupcollaborator
- Swiss Pediatric Oncology Groupcollaborator
Study Sites (87)
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
Vienna, 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
Kliniken der Stadt Köln
Cologne, Germany
Universitätsklinikum
Cologne, 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 im Breisgau, Germany
Universitätsklinikum
Giessen, Germany
Universitätsklinikum
Göttingen, Germany
Universitätsklinikum
Greifswald, Germany
Universitätsklinikum
Halle, Germany
Universitätsklinikum
Hamburg, Germany
Medizinische Hochschule
Hanover, 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
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
Nuremberg, 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
Bialystok, Poland
Collegium Medicum
Bydgoszcz, Poland
Medical Academy
Gdansk, Poland
Silesian Medical Academy
Katowice, Poland
Polish-American Institute of Paediatrics Jagiellonian University Medical College
Krakow, Poland
Medical Academy
Lodz, Poland
Medical Academy
Lublin, Poland
Pian Medical University
Szczecin, Poland
Department of Surgical Oncology for Children and Youth
Warsaw, Poland
Medical University
Wroclaw, Poland
Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital
Gothenburg, 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
Umeå, 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
Geneva, Switzerland
CHUV
Lausanne, Switzerland
Kinderspital
Lucerne, Switzerland
Ostschweizer Kinderspital
Sankt Gallen, Switzerland
University Children's Hospital
Zurich, Switzerland
Related Publications (9)
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.
PMID: 19224858BACKGROUNDMattke 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.
PMID: 19165889BACKGROUNDDantonello 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.
PMID: 18202417BACKGROUNDWeihkopf T, Blettner M, Dantonello T, Jung I, Klingebiel T, Koscielniak E, Luckel 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. doi: 10.1016/j.ejca.2007.11.013.
PMID: 18077150BACKGROUNDKoscielniak E, Morgan M, Treuner J. Soft tissue sarcoma in children: prognosis and management. Paediatr Drugs. 2002;4(1):21-8. doi: 10.2165/00128072-200204010-00003.
PMID: 11817983BACKGROUNDDantonello 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.
PMID: 21370403BACKGROUNDSiepermann 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.
PMID: 22076833BACKGROUNDKlingebiel 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 the HD CWS-96 trial. Pediatr Blood Cancer. 2008 Apr;50(4):739-45. doi: 10.1002/pbc.21494.
PMID: 18286501RESULTKoscielniak E, Ljungman G, Kazanowska B, Niggli F, Sparber-Sauer M, Handgretinger R, Zimmermann M, Boos J, Blank B, Hallmen E, Teichert von Luttichau I, Schmid I, Frohlich B, Muller HL, Behnisch W, Ladenstein R, Scheer M, Vokuhl C, von Kalle T, Blattmann C, Bielack S, Klingebiel T. Maintenance therapy with trofosfamide, idarubicin and etoposide in patients with rhabdomyosarcoma and other high-risk soft tissue sarcomas (CWS-2007-HR): a multicentre, open-label, randomised controlled phase 3 trial. EClinicalMedicine. 2024 Nov 29;78:102957. doi: 10.1016/j.eclinm.2024.102957. eCollection 2024 Dec.
PMID: 39687431DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ewa Koscielniak, MD
Olgahospital, CWS
- STUDY CHAIR
Thomas Klingebiel, MD
Universitätsklinikum Frankfurt, CWS
- STUDY DIRECTOR
Monika Sparber Sauer, MD
Olgahospital, CWS
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 6, 2009
Study Start
July 1, 2009
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
November 8, 2022
Record last verified: 2022-11