EUCTR2010-023035-42-IT进行中（未招募）不适用
Randomized phase III study evaluating hyperthermic intraperitonealchemotherapy in the treatment of ovarian cancer relapse. - CHIPOR
ICANCER0 个研究点开始时间: 2015年3月23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
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, tubal peritoneal primitive
- •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 (pegylated liposomal doxorubicine: with gemcitabine, trabectidine, hycamtin authorized)
- •6. Complete cytoreductive surgery,
- •7. Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 12 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/min) calculated with MDRD method,
- •10. Hematological functions : PNN ³ 1.5x109/L, platelets ³ 100x10^9/L,
- •11. No contraindication to general anesthesia for heavy surgery
- •12. Patient must be informed and the Informed Consent Form signed before any studyspecific 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 222
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 222
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 within 8 weeks before surgery
- •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
- •17) Patient who has already been enrolled in another clinical trial
研究者
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