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

November 3, 2022 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Dornbirn, Austria
        • Krankenhaus der Stadt Dornbirn
      • Graz, Austria
        • Universitätsklinik für Kinder- und Jugendheilkunde
      • Innsbruck, Austria
        • Universitätsklinik für Kinder- und Jugendheilkunde
      • Klagenfurt, Austria
        • Landeskrankenhaus
      • Leoben, Austria
        • Landeskrankenhaus
      • Linz, Austria
        • Landesfrauen - und Kinderklinik Linz
      • Salzburg, Austria
        • St. Johanns Spital / Landeskrankenhaus
      • Wien, Austria
        • St. Anna Kinderspital
  • Germany
      • Aachen, Germany
        • Universitätsklinikum
      • Augsburg, Germany
        • Klinikum Augsburg
      • Berlin, Germany
        • Charité
      • Berlin, Germany
        • Helios Klinikum Berlin-Buch
      • Bielefeld, Germany
        • Krankenhaus Bielefeld
      • Bonn, Germany
        • Universitätskinderklinik
      • Braunschweig, Germany
        • Klinikum Braunschweig
      • Bremen, Germany
        • Prof. Hess Kinderklinik
      • Chemnitz, Germany
        • Klinikum Chemnitz
      • Datteln, Germany
        • Vestische Kinderklinik
      • Dortmund, Germany
        • Westfälisches Kinderzentrum, Klinikum Dortmund
      • Dresden, Germany
        • Universitätsklinikum
      • Düsseldorf, Germany
        • Universitätskinderklinik
      • Erfurt, Germany
        • Helios Klinikum
      • Erlangen, Germany
        • Universitätsklinikum
      • Essen, Germany
        • Universitätsklinikum
      • Frankfurt, Germany
        • Universitätsklinikum
      • Freiburg, Germany
        • Universitätsklinikum
      • Giessen, Germany
        • Universitätsklinikum
      • Greifswald, Germany
        • Universitätsklinikum
      • Göttingen, Germany
        • Universitätsklinikum
      • Halle, Germany
        • Universitätsklinikum
      • Hamburg, Germany
        • Universitätsklinikum
      • Hannover, Germany
        • Medizinische Hochschule
      • Heidelberg, Germany
        • Universitätsklinikum
      • Herdecke, Germany
        • Gemeinschaftskrankenhaus Herdecke
      • Homburg, Germany
        • Universitätsklinikum
      • Jena, Germany
        • Universitätsklinikum
      • Karlsruhe, Germany
        • Stadtisches Klinikum Karlsruhe
      • Kassel, Germany
        • Klinikum Kassel
      • Kiel, Germany
        • Universitätsklinikum
      • Koblenz, Germany
        • Gemeinschaftsklinikum Mayen-Koblenz
      • Köln, Germany
        • Kliniken der Stadt Koln
      • Köln, Germany
        • Universitätsklinikum
      • Leipzig, Germany
        • Universitätsklinikum
      • Lübeck, Germany
        • Universitätsklinikum
      • Magdeburg, Germany
        • Universitätsklinikum
      • Mainz, Germany
        • Universitätsklinikum
      • Mannheim, Germany
        • Universitätsklinikum
      • Minden, Germany
        • Klinikum Minden
      • München, Germany
        • Dr. von Haunersches Kinderspital
      • München, Germany
        • Krankenhaus Munchen Schwabing
      • Münster, Germany
        • Universitätsklinikum
      • Nürnberg, Germany
        • Cnopf'sche Kinderklinik
      • Oldenburg, Germany
        • Klinikum Oldenburg
      • Regensburg, Germany
        • Universitätsklinikum
      • Rostock, Germany
        • Universitätsklinikum
      • Sankt Augustin, Germany
        • Asklepios Kinderklinik
      • Schwerin, Germany
        • Helios Kliniken Schwerin
      • Stuttgart, Germany
        • Olgahospital
      • Trier, Germany
        • Mutterhaus der Borromäerinnen
      • Tübingen, Germany
        • Universitätsklinikum
      • Ulm, Germany
        • Universitätsklinikum
      • Würzburg, Germany
        • Universitätsklinikum
  • Poland
      • Białystok, Poland
        • Medical University
      • Bydgoszcz, Poland
        • Collegium Medicum
      • Gdansk, Poland
        • Medical Academy
      • Katowice, Poland
        • Silesian Medical Academy
      • Kraków, Poland
        • Polish-American Institute of Paediatrics Jagiellonian University Medical College
      • Lublin, Poland
        • Medical Academy
      • Szczecin, Poland
        • Pian Medical University
      • Warszawa, Poland
        • Department of Surgical Oncology for Children and Youth
      • Wroclaw, Poland
        • Medical University
      • Łódź, Poland
        • Medical Academy
  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital
      • Linköping, Sweden
        • University Hospital, Dept. of Pediatrics
      • Lund, Sweden
        • University Hospital, Dept. of Pediatric Hematology and Oncology
      • Stockholm, Sweden
        • Karolinska University Hospital, Astrid Lindgrens Children's Hospital
      • Umea, Sweden
        • Norrland's University Hospital, Dept. of Pediatrics
      • Uppsala, Sweden
        • Children's University Hospital
  • Switzerland
      • Aarau, Switzerland
        • Kantonsspital
      • Basel, Switzerland
        • Universitätskinderklinik beider Basel
      • Bellinzona, Switzerland
        • Ospedale San Giovanni
      • Bern, Switzerland
        • Inselspital University Hospital
      • Geneve, Switzerland
        • Hopital Cantonal de Geneve
      • Lausanne, Switzerland
        • CHUV
      • Luzern, Switzerland
        • Kinderspital
      • Sankt Gallen, Switzerland
        • Ostschweizer Kinderspital
      • Zurich, Switzerland
        • University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
event free survival (EFS)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Deutsche Kinderkrebsstiftung
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Swiss Pediatric Oncology Group
Cooperative Weichteilsarkom Study Group
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria
The Swedish Childhood Solid Tumor Working Group
Polish Paediatric Solid Tumours Study Group

Investigators

  • Principal Investigator: Ewa Koscielniak, MD, Olgahospital, CWS
  • Study Chair: Thomas Klingebiel, MD, Universitätsklinikum Frankfurt, CWS
  • Study Director: Monika Sparber Sauer, MD, Olgahospital, CWS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2009

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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