Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma (CWS-2007-HR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital Tuebingen
Sponsor:
Collaborators:
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
Swiss Pediatric Oncology Group
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00876031
First received: April 2, 2009
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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
Soft Tissue Sarcoma
Drug: trofosfamide, idarubicin, etoposide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • event free survival (EFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2009
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: O-TIE
oral maintenance therapy with trofosfamide, idarubicin, and etoposide
Drug: trofosfamide, idarubicin, etoposide
oral maintenance therapy for 6 months
No Intervention: control

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876031

Contacts
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

  Show 88 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 Working Group for Pediatric Solid Tumours
Polish Paediatric Solid Tumour Study Group
Swiss Pediatric Oncology Group
Investigators
Principal Investigator: Ewa Koscielniak, MD Olgahospital, CWS
Study Chair: Thomas Klingebiel, MD Universitätsklinikum Frankfurt, CWS
Study Director: Tobias M Dantonello, MD Olgahospital, CWS
  More Information

Additional Information:
Publications:

Responsible Party: Prof. Ewa Koscielniak, Prof. Thomas Klingebiel, Cooperative Weichteilsarkom Study Group
ClinicalTrials.gov Identifier: NCT00876031     History of Changes
Other Study ID Numbers: CWS-2007-HR, 4033024 (BfArM), 293/2007AMG1 (Ethikkommission), 2007-001478-10, A2007/14 (Kinderkrebsstiftung), 498 (Krebsstudienregister)
Study First Received: April 2, 2009
Last Updated: August 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Rhabdomyosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Etoposide
Idarubicin
Trofosfamide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 16, 2014