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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 : Recruiting
First Posted : April 6, 2009
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: trofosfamide, idarubicin, etoposide Phase 3

Study Design

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 2019
Estimated Study Completion Date : July 2024

Arms and Interventions

Arm Intervention/treatment
Experimental: O-TIE
oral maintenance therapy with trofosfamide, idarubicin, and etoposide
Drug: trofosfamide, idarubicin, etoposide
oral maintenance therapy for 6 months
No Intervention: control

Outcome Measures

Primary Outcome Measures :
  1. event free survival (EFS) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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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
  • 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)
Contacts and Locations

Information from the National Library of Medicine

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

Contact: Ewa Koscielniak, MD +49-711-2787-2461 e.koscielniak@klinikum-stuttgart.de
Contact: Monika Scheer, MD +49-711-2787-3870 cws@olgahospital-stuttgart.de

  Show 87 Study Locations
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 Childhood Solid Tumor Working Group
Polish Paediatric Solid Tumours Study Group
Swiss Pediatric Oncology Group
Principal Investigator: Ewa Koscielniak, MD Olgahospital, CWS
Study Chair: Thomas Klingebiel, MD Universitätsklinikum Frankfurt, CWS
Study Director: Monika Scheer, MD Olgahospital, CWS
More Information

Additional Information:

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00876031     History of Changes
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: October 26, 2017
Last Verified: October 2017

Keywords provided by University Hospital Tuebingen:
pediatric soft tissue sarcoma
extraosseous Ewing family tumours
synovial sarcoma
undifferentiated sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Etoposide phosphate
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