Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma (CWS-2007-HR)
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ClinicalTrials.gov Identifier: NCT00876031 |
Recruitment Status :
Active, not recruiting
First Posted : April 6, 2009
Last Update Posted : November 15, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Soft Tissue Sarcoma | Drug: trofosfamide, idarubicin, etoposide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 320 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2009 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: O-TIE
oral maintenance therapy with trofosfamide, idarubicin, and etoposide
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Drug: trofosfamide, idarubicin, etoposide
oral maintenance therapy for 6 months |
No Intervention: control |
- event free survival (EFS) [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 5 years ]

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Ages Eligible for Study: | 6 Months to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876031

Principal Investigator: | Ewa Koscielniak, MD | Olgahospital, CWS | |
Study Chair: | Thomas Klingebiel, MD | Universitätsklinikum Frankfurt, CWS | |
Study Director: | Monika Scheer, MD | Olgahospital, CWS |
Publications of Results:
Other Publications:
Responsible Party: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00876031 |
Other Study ID Numbers: |
CWS-2007-HR 4033024 (BfArM) ( Other Identifier: Bundesinstitut für Arzneimittel und Medizinprodukte ) 293/2007AMG1 (Ethikkommission) ( Other Identifier: Ethics Committee University of Tübingen ) 2007-001478-10 ( EudraCT Number ) A2007/14 (Kinderkrebsstiftung) ( Other Identifier: German Childhood Cancer Foundation ) 498 (Krebsstudienregister) ( Registry Identifier: Krebsstudienregister ) |
First Posted: | April 6, 2009 Key Record Dates |
Last Update Posted: | November 15, 2021 |
Last Verified: | November 2021 |
pediatric soft tissue sarcoma rhabdomyosarcoma extraosseous Ewing family tumours synovial sarcoma undifferentiated sarcoma |
Sarcoma Rhabdomyosarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Myosarcoma Neoplasms, Muscle Tissue Etoposide Idarubicin Trofosfamide Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents |