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Soft Tissue SarcomaPhase 3CWS-2007-HRNCT00876031

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

A Phase 3 study testing trofosfamide, idarubicin, etoposide in people with Soft Tissue Sarcoma, run by University Hospital Tuebingen at 87 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 months to 21 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
trofosfamide, idarubicin, etoposide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
87 sitesin 5 countries
Study dates
1 Jul 2009to 30 Jun 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

87 sites in 5 countries.

87 sites in 5 countries

Germany54 sites

  • Universitätsklinikum

    Aachen

  • Klinikum Augsburg

    Augsburg

  • Charité

    Berlin

  • Helios Klinikum Berlin-Buch

    Berlin

  • Krankenhaus Bielefeld

    Bielefeld

  • Universitätskinderklinik

    Bonn

  • Klinikum Braunschweig

    Braunschweig

  • Prof. Hess Kinderklinik

    Bremen

  • Klinikum Chemnitz

    Chemnitz

  • Kliniken der Stadt Köln

    Cologne

  • Universitätsklinikum

    Cologne

  • Vestische Kinderklinik

    Datteln

  • Westfälisches Kinderzentrum, Klinikum Dortmund

    Dortmund

  • Universitätsklinikum

    Dresden

  • Universitätskinderklinik

    Düsseldorf

  • Helios Klinikum

    Erfurt

  • Universitätsklinikum

    Erlangen

  • Universitätsklinikum

    Essen

  • Universitätsklinikum

    Frankfurt

  • Universitätsklinikum

    Freiburg im Breisgau

  • Universitätsklinikum

    Giessen

  • Universitätsklinikum

    Göttingen

  • Universitätsklinikum

    Greifswald

  • Universitätsklinikum

    Halle

  • Universitätsklinikum

    Hamburg

  • Medizinische Hochschule

    Hanover

  • Universitätsklinikum

    Heidelberg

  • Gemeinschaftskrankenhaus Herdecke

    Herdecke

  • Universitätsklinikum

    Homburg

  • Universitätsklinikum

    Jena

  • Städtisches Klinikum Karlsruhe

    Karlsruhe

  • Klinikum Kassel

    Kassel

  • Universitätsklinikum

    Kiel

  • Gemeinschaftsklinikum Mayen-Koblenz

    Koblenz

  • Universitätsklinikum

    Leipzig

  • Universitätsklinikum

    Lübeck

  • Universitätsklinikum

    Magdeburg

  • Universitätsklinikum

    Mainz

  • Universitätsklinikum

    Mannheim

  • Klinikum Minden

    Minden

  • Dr. von Haunersches Kinderspital

    München

  • Krankenhaus München Schwabing

    München

  • Universitätsklinikum

    Münster

  • Cnopf'sche Kinderklinik

    Nuremberg

  • Klinikum Oldenburg

    Oldenburg

  • Universitätsklinikum

    Regensburg

  • Universitätsklinikum

    Rostock

  • Asklepios Kinderklinik

    Sankt Augustin

  • Helios Kliniken Schwerin

    Schwerin

  • Olgahospital

    Stuttgart

  • Mutterhaus der Borromäerinnen

    Trier

  • Universitätsklinikum

    Tübingen

  • Universitätsklinikum

    Ulm

  • Universitätsklinikum

    Würzburg

Other trials in Germany

Poland10 sites

  • Medical University

    Bialystok

  • Collegium Medicum

    Bydgoszcz

  • Medical Academy

    Gdansk

  • Silesian Medical Academy

    Katowice

  • Polish-American Institute of Paediatrics Jagiellonian University Medical College

    Krakow

  • Medical Academy

    Lodz

  • Medical Academy

    Lublin

  • Pian Medical University

    Szczecin

  • Department of Surgical Oncology for Children and Youth

    Warsaw

  • Medical University

    Wroclaw

Other trials in Poland

Switzerland9 sites

  • Kantonsspital

    Aarau

  • Universitätskinderklinik beider Basel

    Basel

  • Ospedale San Giovanni

    Bellinzona

  • Inselspital University hospital

    Bern

  • Hopital Cantonal de Geneve

    Geneva

  • CHUV

    Lausanne

  • Kinderspital

    Lucerne

  • Ostschweizer Kinderspital

    Sankt Gallen

  • University Children's Hospital

    Zurich

Other trials in Switzerland

Austria8 sites

  • Krankenhaus der Stadt Dornbirn

    Dornbirn

  • Universitätsklinik für Kinder- und Jugendheilkunde

    Graz

  • Universitätsklinik für Kinder- und Jugendheilkunde

    Innsbruck

  • Landeskrankenhaus

    Klagenfurt

  • Landeskrankenhaus

    Leoben

  • Landesfrauen - und Kinderklinik Linz

    Linz

  • St. Johanns Spital / Landeskrankenhaus

    Salzburg

  • St. Anna Kinderspital

    Vienna

Other trials in Austria

Sweden6 sites

  • Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital

    Gothenburg

  • University Hospital, Dept. of Pediatrics

    Linköping

  • University Hospital, Dept. of Pediatric Hematology and Oncology

    Lund

  • Karolinska University Hospital, Astrid Lindgrens Children's Hospital

    Stockholm

  • Norrland's University Hospital, Dept. of Pediatrics

    Umeå

  • Children's University Hospital

    Uppsala

Other trials in Sweden

About this study

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

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.

Being tested
trofosfamide, idarubicin, etoposide
Keywords
pediatric soft tissue sarcoma, rhabdomyosarcoma, extraosseous Ewing family tumours, synovial sarcoma, undifferentiated sarcoma
Medical subject headings
Sarcoma, Rhabdomyosarcoma, Sarcoma, Synovial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trofosfamide, idarubicin, etoposideDrug

    oral maintenance therapy for 6 months

Study groups in NCT00876031
Study groupRoleWhat they receive
O-TIEExperimentaloral maintenance therapy with trofosfamide, idarubicin, and etoposide
Receives: Drug: trofosfamide, idarubicin, etoposide
controlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. event free survival (EFS)

    Measured: 3 years

Secondary outcomes (1)

  1. Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2009 (estimated)
  2. Study start1 Jul 2009
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00876031
Sponsor's protocol ID
CWS-2007-HR
Other IDs
4033024 (BfArM), 293/2007AMG1 (Ethikkommission), 2007-001478-10, A2007/14 (Kinderkrebsstiftung), 498 (Krebsstudienregister)
Acronym
CWS-2007-HR
Status last verified
Nov 2022
First submitted
2 Apr 2009
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19224858

  • 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.

    PubMed 19165889

  • 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.

    PubMed 18202417

  • 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.

    PubMed 18077150

  • 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.

    PubMed 11817983

  • 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.

    PubMed 21370403

  • 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.

    PubMed 22076833

  • 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.

    PubMed 18286501

  • Koscielniak E, Ljungman G, Kazanowska B, Niggli F, Sparber-Sauer M, Handgretinger R, Zimmermann M, Boos J, Blank B, Hallmen E, Teichert von Luttichau I, Schmid I, Frohlich B, Muller HL, Behnisch W, Ladenstein R, Scheer M, Vokuhl C, von Kalle T, Blattmann C, Bielack S, Klingebiel T. Maintenance therapy with trofosfamide, idarubicin and etoposide in patients with rhabdomyosarcoma and other high-risk soft tissue sarcomas (CWS-2007-HR): a multicentre, open-label, randomised controlled phase 3 trial. EClinicalMedicine. 2024 Nov 29;78:102957. doi: 10.1016/j.eclinm.2024.102957. eCollection 2024 Dec.

    PubMed 39687431

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing trofosfamide, idarubicin, etoposide in people with Soft Tissue Sarcoma, run by University Hospital Tuebingen at 87 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Germany, Poland, Switzerland, Austria, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

event free survival (EFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00876031, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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