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

Primary Purpose

Soft Tissue Sarcoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
trofosfamide, idarubicin, etoposide
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring pediatric soft tissue sarcoma, rhabdomyosarcoma, extraosseous Ewing family tumours, synovial sarcoma, undifferentiated sarcoma

Eligibility Criteria

6 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Krankenhaus der Stadt Dornbirn
  • Universitätsklinik für Kinder- und Jugendheilkunde
  • Universitätsklinik für Kinder- und Jugendheilkunde
  • Landeskrankenhaus
  • Landeskrankenhaus
  • Landesfrauen - und Kinderklinik Linz
  • St. Johanns Spital / Landeskrankenhaus
  • St. Anna Kinderspital
  • Universitätsklinikum
  • Klinikum Augsburg
  • Charité
  • Helios Klinikum Berlin-Buch
  • Krankenhaus Bielefeld
  • Universitätskinderklinik
  • Klinikum Braunschweig
  • Prof. Hess Kinderklinik
  • Klinikum Chemnitz
  • Vestische Kinderklinik
  • Westfälisches Kinderzentrum, Klinikum Dortmund
  • Universitätsklinikum
  • Universitätskinderklinik
  • Helios Klinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Medizinische Hochschule
  • Universitätsklinikum
  • Gemeinschaftskrankenhaus Herdecke
  • Universitätsklinikum
  • Universitätsklinikum
  • Städtisches Klinikum Karlsruhe
  • Klinikum Kassel
  • Universitätsklinikum
  • Gemeinschaftsklinikum Mayen-Koblenz
  • Kliniken der Stadt Köln
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Klinikum Minden
  • Dr. von Haunersches Kinderspital
  • Krankenhaus München Schwabing
  • Universitätsklinikum
  • Cnopf'sche Kinderklinik
  • Klinikum Oldenburg
  • Universitätsklinikum
  • Universitätsklinikum
  • Asklepios Kinderklinik
  • Helios Kliniken Schwerin
  • Olgahospital
  • Mutterhaus der Borromäerinnen
  • Universitätsklinikum
  • Universitätsklinikum
  • Universitätsklinikum
  • Medical University
  • Collegium Medicum
  • Medical Academy
  • Silesian Medical Academy
  • Polish-American Institute of Paediatrics Jagiellonian University Medical College
  • Medical Academy
  • Pian Medical University
  • Department of Surgical Oncology for Children and Youth
  • Medical University
  • Medical Academy
  • Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital
  • University Hospital, Dept. of Pediatrics
  • University Hospital, Dept. of Pediatric Hematology and Oncology
  • Karolinska University Hospital, Astrid Lindgrens Children's Hospital
  • Norrland's University Hospital, Dept. of Pediatrics
  • Children's University Hospital
  • Kantonsspital
  • Universitätskinderklinik beider Basel
  • Ospedale San Giovanni
  • Inselspital University hospital
  • Hopital Cantonal de Geneve
  • CHUV
  • Kinderspital
  • Ostschweizer Kinderspital
  • University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

O-TIE

control

Arm Description

oral maintenance therapy with trofosfamide, idarubicin, and etoposide

Outcomes

Primary Outcome Measures

event free survival (EFS)

Secondary Outcome Measures

Overall survival

Full Information

First Posted
April 2, 2009
Last Updated
November 3, 2022
Sponsor
University Hospital Tuebingen
Collaborators
Cooperative Weichteilsarkom Study Group, Deutsche Kinderkrebsstiftung, German Society for Pediatric Oncology and Hematology GPOH gGmbH, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria, The Swedish Childhood Solid Tumor Working Group, Polish Paediatric Solid Tumours Study Group, Swiss Pediatric Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00876031
Brief Title
Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
Acronym
CWS-2007-HR
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2009 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Cooperative Weichteilsarkom Study Group, Deutsche Kinderkrebsstiftung, German Society for Pediatric Oncology and Hematology GPOH gGmbH, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria, The Swedish Childhood Solid Tumor Working Group, Polish Paediatric Solid Tumours Study Group, Swiss Pediatric Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
pediatric soft tissue sarcoma, rhabdomyosarcoma, extraosseous Ewing family tumours, synovial sarcoma, undifferentiated sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
O-TIE
Arm Type
Experimental
Arm Description
oral maintenance therapy with trofosfamide, idarubicin, and etoposide
Arm Title
control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
trofosfamide, idarubicin, etoposide
Intervention Description
oral maintenance therapy for 6 months
Primary Outcome Measure Information:
Title
event free survival (EFS)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Koscielniak, MD
Organizational Affiliation
Olgahospital, CWS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Klingebiel, MD
Organizational Affiliation
Universitätsklinikum Frankfurt, CWS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Monika Sparber Sauer, MD
Organizational Affiliation
Olgahospital, CWS
Official's Role
Study Director
Facility Information:
Facility Name
Krankenhaus der Stadt Dornbirn
City
Dornbirn
Country
Austria
Facility Name
Universitätsklinik für Kinder- und Jugendheilkunde
City
Graz
Country
Austria
Facility Name
Universitätsklinik für Kinder- und Jugendheilkunde
City
Innsbruck
Country
Austria
Facility Name
Landeskrankenhaus
City
Klagenfurt
Country
Austria
Facility Name
Landeskrankenhaus
City
Leoben
Country
Austria
Facility Name
Landesfrauen - und Kinderklinik Linz
City
Linz
Country
Austria
Facility Name
St. Johanns Spital / Landeskrankenhaus
City
Salzburg
Country
Austria
Facility Name
St. Anna Kinderspital
City
Wien
Country
Austria
Facility Name
Universitätsklinikum
City
Aachen
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Charité
City
Berlin
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
Country
Germany
Facility Name
Krankenhaus Bielefeld
City
Bielefeld
Country
Germany
Facility Name
Universitätskinderklinik
City
Bonn
Country
Germany
Facility Name
Klinikum Braunschweig
City
Braunschweig
Country
Germany
Facility Name
Prof. Hess Kinderklinik
City
Bremen
Country
Germany
Facility Name
Klinikum Chemnitz
City
Chemnitz
Country
Germany
Facility Name
Vestische Kinderklinik
City
Datteln
Country
Germany
Facility Name
Westfälisches Kinderzentrum, Klinikum Dortmund
City
Dortmund
Country
Germany
Facility Name
Universitätsklinikum
City
Dresden
Country
Germany
Facility Name
Universitätskinderklinik
City
Düsseldorf
Country
Germany
Facility Name
Helios Klinikum
City
Erfurt
Country
Germany
Facility Name
Universitätsklinikum
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum
City
Essen
Country
Germany
Facility Name
Universitätsklinikum
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinikum
City
Freiburg
Country
Germany
Facility Name
Universitätsklinikum
City
Giessen
Country
Germany
Facility Name
Universitätsklinikum
City
Greifswald
Country
Germany
Facility Name
Universitätsklinikum
City
Göttingen
Country
Germany
Facility Name
Universitätsklinikum
City
Halle
Country
Germany
Facility Name
Universitätsklinikum
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum
City
Heidelberg
Country
Germany
Facility Name
Gemeinschaftskrankenhaus Herdecke
City
Herdecke
Country
Germany
Facility Name
Universitätsklinikum
City
Homburg
Country
Germany
Facility Name
Universitätsklinikum
City
Jena
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe
City
Karlsruhe
Country
Germany
Facility Name
Klinikum Kassel
City
Kassel
Country
Germany
Facility Name
Universitätsklinikum
City
Kiel
Country
Germany
Facility Name
Gemeinschaftsklinikum Mayen-Koblenz
City
Koblenz
Country
Germany
Facility Name
Kliniken der Stadt Köln
City
Köln
Country
Germany
Facility Name
Universitätsklinikum
City
Köln
Country
Germany
Facility Name
Universitätsklinikum
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum
City
Lübeck
Country
Germany
Facility Name
Universitätsklinikum
City
Magdeburg
Country
Germany
Facility Name
Universitätsklinikum
City
Mainz
Country
Germany
Facility Name
Universitätsklinikum
City
Mannheim
Country
Germany
Facility Name
Klinikum Minden
City
Minden
Country
Germany
Facility Name
Dr. von Haunersches Kinderspital
City
München
Country
Germany
Facility Name
Krankenhaus München Schwabing
City
München
Country
Germany
Facility Name
Universitätsklinikum
City
Münster
Country
Germany
Facility Name
Cnopf'sche Kinderklinik
City
Nürnberg
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
Country
Germany
Facility Name
Universitätsklinikum
City
Regensburg
Country
Germany
Facility Name
Universitätsklinikum
City
Rostock
Country
Germany
Facility Name
Asklepios Kinderklinik
City
Sankt Augustin
Country
Germany
Facility Name
Helios Kliniken Schwerin
City
Schwerin
Country
Germany
Facility Name
Olgahospital
City
Stuttgart
Country
Germany
Facility Name
Mutterhaus der Borromäerinnen
City
Trier
Country
Germany
Facility Name
Universitätsklinikum
City
Tübingen
Country
Germany
Facility Name
Universitätsklinikum
City
Ulm
Country
Germany
Facility Name
Universitätsklinikum
City
Würzburg
Country
Germany
Facility Name
Medical University
City
Białystok
Country
Poland
Facility Name
Collegium Medicum
City
Bydgoszcz
Country
Poland
Facility Name
Medical Academy
City
Gdansk
Country
Poland
Facility Name
Silesian Medical Academy
City
Katowice
Country
Poland
Facility Name
Polish-American Institute of Paediatrics Jagiellonian University Medical College
City
Kraków
Country
Poland
Facility Name
Medical Academy
City
Lublin
Country
Poland
Facility Name
Pian Medical University
City
Szczecin
Country
Poland
Facility Name
Department of Surgical Oncology for Children and Youth
City
Warszawa
Country
Poland
Facility Name
Medical University
City
Wroclaw
Country
Poland
Facility Name
Medical Academy
City
Łódź
Country
Poland
Facility Name
Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital
City
Göteborg
Country
Sweden
Facility Name
University Hospital, Dept. of Pediatrics
City
Linköping
Country
Sweden
Facility Name
University Hospital, Dept. of Pediatric Hematology and Oncology
City
Lund
Country
Sweden
Facility Name
Karolinska University Hospital, Astrid Lindgrens Children's Hospital
City
Stockholm
Country
Sweden
Facility Name
Norrland's University Hospital, Dept. of Pediatrics
City
Umea
Country
Sweden
Facility Name
Children's University Hospital
City
Uppsala
Country
Sweden
Facility Name
Kantonsspital
City
Aarau
Country
Switzerland
Facility Name
Universitätskinderklinik beider Basel
City
Basel
Country
Switzerland
Facility Name
Ospedale San Giovanni
City
Bellinzona
Country
Switzerland
Facility Name
Inselspital University hospital
City
Bern
Country
Switzerland
Facility Name
Hopital Cantonal de Geneve
City
Geneve
Country
Switzerland
Facility Name
CHUV
City
Lausanne
Country
Switzerland
Facility Name
Kinderspital
City
Luzern
Country
Switzerland
Facility Name
Ostschweizer Kinderspital
City
Sankt Gallen
Country
Switzerland
Facility Name
University Children's Hospital
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19224858
Citation
Dantonello TM, Int-Veen C, Harms D, Leuschner I, Schmidt BF, Herbst M, Juergens H, Scheel-Walter HG, Bielack SS, Klingebiel T, Dickerhoff R, Kirsch S, Brecht I, Schmelzle R, Greulich M, Gadner H, Greiner J, Marky I, Treuner J, Koscielniak E. Cooperative trial CWS-91 for localized soft tissue sarcoma in children, adolescents, and young adults. J Clin Oncol. 2009 Mar 20;27(9):1446-55. doi: 10.1200/JCO.2007.15.0466. Epub 2009 Feb 17.
Results Reference
background
PubMed Identifier
19165889
Citation
Mattke AC, Bailey EJ, Schuck A, Dantonello T, Leuschner I, Klingebiel T, Treuner J, Koscielniak E. Does the time-point of relapse influence outcome in pediatric rhabdomyosarcomas? Pediatr Blood Cancer. 2009 Jul;52(7):772-6. doi: 10.1002/pbc.21906.
Results Reference
background
PubMed Identifier
18202417
Citation
Dantonello TM, Int-Veen C, Winkler P, Leuschner I, Schuck A, Schmidt BF, Lochbuehler H, Kirsch S, Hallmen E, Veit-Friedrich I, Bielack SS, Niggli F, Kazanowska B, Ladenstein R, Wiebe T, Klingebiel T, Treuner J, Koscielniak E. Initial patient characteristics can predict pattern and risk of relapse in localized rhabdomyosarcoma. J Clin Oncol. 2008 Jan 20;26(3):406-13. doi: 10.1200/JCO.2007.12.2382. Erratum In: J Clin Oncol.2008 Apr 10;26(11) 1911.
Results Reference
background
PubMed Identifier
18077150
Citation
Weihkopf T, Blettner M, Dantonello T, Jung I, Klingebiel T, Koscielniak E, Luckel M, Spix C, Kaatsch P. Incidence and time trends of soft tissue sarcomas in German children 1985-2004 - a report from the population-based German Childhood Cancer Registry. Eur J Cancer. 2008 Feb;44(3):432-40. doi: 10.1016/j.ejca.2007.11.013.
Results Reference
background
PubMed Identifier
11817983
Citation
Koscielniak E, Morgan M, Treuner J. Soft tissue sarcoma in children: prognosis and management. Paediatr Drugs. 2002;4(1):21-8. doi: 10.2165/00128072-200204010-00003.
Results Reference
background
PubMed Identifier
21370403
Citation
Dantonello TM, Winkler P, Boelling T, Friedel G, Schmid I, Mattke AC, Ljungman G, Bielack SS, Klingebiel T, Koscielniak E; CWS Study Group. Embryonal rhabdomyosarcoma with metastases confined to the lungs: report from the CWS Study Group. Pediatr Blood Cancer. 2011 May;56(5):725-32. doi: 10.1002/pbc.22862. Epub 2010 Nov 8.
Results Reference
background
PubMed Identifier
22076833
Citation
Siepermann M, Koscielniak E, Dantonello T, Klee D, Boos J, Krefeld B, Borkhardt A, Hoehn T, Asea A, Wessalowski R. Oral low-dose chemotherapy: successful treatment of an alveolar rhabdomyosarcoma during pregnancy. Pediatr Blood Cancer. 2012 Jan;58(1):104-6. doi: 10.1002/pbc.22934. Epub 2011 Jan 16.
Results Reference
background
PubMed Identifier
18286501
Citation
Klingebiel T, Boos J, Beske F, Hallmen E, Int-Veen C, Dantonello T, Treuner J, Gadner H, Marky I, Kazanowska B, Koscielniak E. Treatment of children with metastatic soft tissue sarcoma with oral maintenance compared to high dose chemotherapy: report of the HD CWS-96 trial. Pediatr Blood Cancer. 2008 Apr;50(4):739-45. doi: 10.1002/pbc.21494.
Results Reference
result
Links:
URL
http://www.kinderkrebsinfo.de/
Description
Related Info
URL
http://cws.olgahospital-stuttgart.de
Description
homepage of CWS Study Group

Learn more about this trial

Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma

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