EUCTR2005-001139-31-BE进行中（未招募）1 期
European Paediatric Soft Tissue Sarcoma Study Group protocol for Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas 2005 - NRSTS 2005
CHC-Clinique Espérance0 个研究点目标入组 250 人开始时间: 2006年6月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •Eligibility criteria for the prospective non-randomized historically-controlled trial are the following:
- •?A pathologically proven diagnosis of synovial sarcoma and adult-type soft tissue sarcomas
- •?No evidence of metastatic lesions
- •?Age less than 21 years (20 years and 364 days) of age
- •?No previous treatment except for primary surgery
- •?For patients who require adjuvant chemotherapy according to protocol guidelines, no more than a 8 week-interval between the diagnostic surgical approach and the start of chemotherapy
- •?For patients who require adjuvant chemotherapy according to protocol guidelines, no pre-existing illness preventing treatment (in particular renal function must be equivalent to grade 0-1 nephrotoxicity, no prior history of cardiac disease and normal shortening fraction [> 28%] and ejection fraction [> 47%])
- •?No previous malignancy
- •Patients with post-irradiation soft part sarcomas could be registered and treated according to the protocol guidelines, but they will be analysed separately
- •?Diagnostic material available for pathology review
- •?Available for long term follow up through the treatment centre
- •?Written informed consent for treatment available.
- •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
排除标准
- •Absence of any of the above
研究者
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