EUCTR2007-001478-10-SEActive, not recruitingNot Applicable
CWS-2007-HR: A randomised phase-III trial of the Cooperative Weichteilsarkom Studiengruppe for localised high-risk Rhabdomyosarcoma and localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in children, adolescents, and young adults - CWS-2007-HR
niversitätsklinikum Tübingen0 sites320 target enrollmentStarted: February 10, 2011Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 320
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •age > 6 months and <21 years at the time of randomisation
- •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)
- •Rhabdomyosarcoma of the Very High Risk” Group, i.e.:
- •- RMA, N1, MO, IRS II&III, any size or age
- •- 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
- •no previous malignant tumours
- •available for long term follow up through the treating centre
- •in remission (according to the CWS-2007-HR definition (see 7.1.8)) at the
- •time of randomisation after standard multimodal therapy e.g. according to the
- •CWS-guidance for 25 weeks
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •pregnant or lactating women
- •other medical condition precluding treatment with protocol
- •(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)
Investigators
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