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Sponsors and Collaborators: |
University Hospital Tuebingen Cooperative Weichteilsarkom Study Group Deutsche Kinderkrebsstiftung Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria The Swedish Working Group for Pediatric Solid Tumours Polish Paediatric Solid Tumour Study Group Gesellschaft für Pädiatrische Onkologie und Hämatologie - Switzerland |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00876031 |
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.
Condition | Intervention | Phase |
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Soft Tissue Sarcoma |
Drug: trofosfamide, idarubicin, etoposide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 320 |
Study Start Date: | July 2009 |
Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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O-TIE: Experimental
oral maintenance therapy with trofosfamide, idarubicin, and etoposide
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Drug: trofosfamide, idarubicin, etoposide
oral maintenance therapy for 6 months
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control: No Intervention |
Ages Eligible for Study: | 6 Months to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Rhabdomyosarcoma of the "High Risk" Group, i.e.:
Rhabdomyosarcoma of the "Very High Risk" Group, i.e.:
Exclusion Criteria:
Contact: Ewa Koscielniak, MD | +49-711-2787-2461 | e.koscielniak@klinikum-stuttgart.de |
Contact: Tobias M Dantonello, MD | +49-711-2787-3870 | cws@olgahospital-stuttgart.de |
Principal Investigator: | Ewa Koscielniak, MD | Olgahospital, CWS |
Study Chair: | Thomas Klingebiel, MD | Universitätsklinikum Frankfurt, CWS |
Study Director: | Tobias M Dantonello, MD | Olgahospital, CWS |
Responsible Party: | Cooperative Weichteilsarkom Study Group ( Prof. Ewa Koscielniak, Prof. Thomas Klingebiel ) |
Study ID Numbers: | CWS-2007-HR, 4033024 (BfArM), 293/2007AMG1 (Ethikkommission), 2007-001478-10 (EUDRACT), A2007/14 (Kinderkrebsstiftung), 498 (Krebsstudienregister) |
Study First Received: | April 2, 2009 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00876031 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
pediatric soft tissue sarcoma rhabdomyosarcoma extraosseaous Ewing family tumours synovial sarcoma undifferentiated sarcoma |
Immunologic Factors Immunosuppressive Agents Etoposide phosphate Sarcoma, Synovial Trofosfamide Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas |
Idarubicin Sarcoma Synovial Sarcoma Antineoplastic Agents, Alkylating Etoposide Alkylating Agents Rhabdomyosarcoma |
Neoplasms, Muscle Tissue Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Myosarcoma Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Trofosfamide Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Antineoplastic Agents, Alkylating Alkylating Agents Rhabdomyosarcoma |