EUCTR2010-023035-42-ES进行中（未招募）不适用
Randomized phase III study evaluating hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer relapse - CHIPOR
nicancer0 个研究点目标入组 444 人开始时间: 2012年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 444
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
- •1.Patient age ? 18 years,
- •2.Performance Status WHO < 2,
- •3.Previous treatment for epithelial ovarian cancer,
- •4.Patient with intraperitoneal relapse (more than 6 months after the end of the initial treatment), resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal) ,
- •5.Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix,
- •6.Complete cytoreductive surgery,
- •7.Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 8 weeks,
- •8.No hepatic insufficiency (bilirubin ? 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT ? 3 ULN),
- •9.No renal insufficiency (creatinine ? 1.5 ULN, creatinine clearance >60 ml/mn) calculated with MDRD method.
- •10. Hematological functions : PNN ? 1.5x109/L, platelets ? 100x109/L,
- •11. No contraindication to general anesthesia,
- •12.Patient must be informed and the Informed Consent Form signed before any study-specific procedures start.
- •13.Medical/Public Health insurance coverage
- •14.Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
- •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 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1)Patient age <18 years,
- •2)Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),
- •3)Known hypersensitivity to cisplatin,
- •4)Metastasis,
- •5)Use of anti-angiogenic treatment,
- •6)Patient with other concomitant severe life threatening disease,
- •7)More than 2 segmental resections concomitant to HIPEC is foreseen,
- •8)Any progressive disease during the second-line chemotherapy (platine-based),
- •9)Relapse occurring less than 6 months after the end of the initial treatment,
- •10)Non-epithelial ovarian tumor,
- •11)Uncontrolled infection,
- •12)Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
- •13)Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
- •14) Patient who has already been treated by HIPEC for ovarian cancer,
- •15)Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,
- •16)Pregnant or breastfeeding woman
研究者
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