EUCTR2007-001478-10-DE进行中（未招募）不适用
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 个研究点目标入组 320 人开始时间: 2008年7月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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: 275
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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)
研究者
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