Status:
COMPLETED
Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Cooperative Weichteilsarkom Study Group
Deutsche Kinderkrebsstiftung
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
6-21 years
Phase:
PHASE3
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) i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00876031
Start Date
July 1 2009
End Date
June 30 2022
Last Update
November 8 2022
Active Locations (87)
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1
Krankenhaus der Stadt Dornbirn
Dornbirn, Austria
2
Universitätsklinik für Kinder- und Jugendheilkunde
Graz, Austria
3
Universitätsklinik für Kinder- und Jugendheilkunde
Innsbruck, Austria
4
Landeskrankenhaus
Klagenfurt, Austria