Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
NCT ID: NCT00876031
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
195 participants
INTERVENTIONAL
2009-07-01
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
NCT00130858
Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
NCT00334854
Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma
NCT02784015
Trabectedin and Irinotecan for Refractory Pediatric Sarcomas
NCT02509234
Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma
NCT00003801
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
O-TIE
oral maintenance therapy with trofosfamide, idarubicin, and etoposide
trofosfamide, idarubicin, etoposide
oral maintenance therapy for 6 months
control
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
trofosfamide, idarubicin, etoposide
oral maintenance therapy for 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
6 Months
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cooperative Weichteilsarkom Study Group
OTHER
Deutsche Kinderkrebsstiftung
OTHER
German Society for Pediatric Oncology and Hematology GPOH gGmbH
OTHER
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria
OTHER
The Swedish Childhood Solid Tumor Working Group
UNKNOWN
Polish Paediatric Solid Tumours Study Group
UNKNOWN
Swiss Pediatric Oncology Group
OTHER
University Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ewa Koscielniak, MD
Role: PRINCIPAL_INVESTIGATOR
Olgahospital, CWS
Thomas Klingebiel, MD
Role: STUDY_CHAIR
Universitätsklinikum Frankfurt, CWS
Monika Sparber Sauer, MD
Role: STUDY_DIRECTOR
Olgahospital, CWS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Weihkopf 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.
Koscielniak 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.
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.
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.
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 the HD CWS-96 trial. Pediatr Blood Cancer. 2008 Apr;50(4):739-45. doi: 10.1002/pbc.21494.
Koscielniak 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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4033024 (BfArM)
Identifier Type: OTHER
Identifier Source: secondary_id
293/2007AMG1 (Ethikkommission)
Identifier Type: OTHER
Identifier Source: secondary_id
2007-001478-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A2007/14 (Kinderkrebsstiftung)
Identifier Type: OTHER
Identifier Source: secondary_id
498 (Krebsstudienregister)
Identifier Type: REGISTRY
Identifier Source: secondary_id
CWS-2007-HR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.