ISRCTN55318937已完成3 期
A multicentre non-randomised interventional treatment trial looking at the treatment of children and young people with non-rhabdomyosarcoma soft tissue sarcomas
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Eligibility criteria for the prospective non-randomised historically-controlled trial are the following:
- •1. A pathologically proven diagnosis of synovial sarcoma and adult-type soft tissue sarcomas
- •2. No evidence of metastatic lesions
- •3. Age less than 21 years (20 years and 364 days) of age
- •4. No previous treatment except for primary surgery
- •5. 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
- •6. 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 [greater than 28%] and ejection fraction [greater than 47%])
- •7. 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.
- •8. Diagnostic material available for pathology review
- •9. Available for long term follow up through the treatment centre
- •10. Written informed consent for treatment available
排除标准
- •Does not meet inclusion criteria
研究者
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