EUCTR2018-003346-17-DK进行中（未招募）1 期
Phase III Randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy:OVHIPEC-2 - OVHIPEC-2
KI-AV0 个研究点目标入组 535 人开始时间: 2020年10月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 535
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
- Female
入选标准
- •- signed and written informed consent
- •- age =18
- •- candidate for primary CRS, in whom a complete cytoreduction, or cytoreducion with no more than 2.5 mm residual disease is considered feasible
- •- histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
- •- fit for major surgery, ASA 1 or ASA 2
- •- WHO performance status 0 t/m2
- •- adequate bone marrow, hepatic and renal function
- •Are the trial subjects under 18? no
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.history of previous malignancies within 5 years prior to inclusion
- •2.FIGO stage IV disease
- •3.if complete primary cytoreduction is impossible
- •4.patients who received prior treatment for the current malignancy
研究者
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