EUCTR2012-002107-17-IE进行中（未招募）1 期
International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours - Euro Ewing 2012
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •Any histologically and genetically confirmed ESFT of bone or soft tissue, or round cell sarcomas 'Ewing's-like'
- •but which are negative for EWSR1 gene rearrangement.
- •Age >2 years and <50 years (from second birthday to 49 years 364 days) at the date of diagnostic biopsy
- •Randomisation =45 days after diagnostic biopsy/surgery
- •Patient assessed as medically fit to receive the treatment in either of the R1 treatment arms
- •No prior treatment for ESFT other than surgery
- •Documented negative pregnancy test for female patients of childbearing potential
- •Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where applicable
- •Written informed consent from the patient and/or the parent/legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 470
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Contra-indication to the treatment in either of the R1 treatment arms
- •Second malignancy
- •Pregnant or breastfeeding women
- •Follow-up not possible due to social, geographic or psychological reasons
研究者
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