2024-517390-24-00招募中3 期
CHIPOR : Randomized phase III study evaluating hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer relapse
Unicancer, Unicancer32 个研究点 分布在 1 个国家目标入组 383 人开始时间: 2024年9月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 383
- 试验地点
- 32
- 主要终点
- The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.
研究概览
简要总结
To improve overall survival at 12 months for patients in arm with HIPEC compared with patients in arm without HIPEC.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient age ≥ 18 years,
- •Hematological functions : PNN > ou = 1.5x109/L, platelets > ou = 100x109/L,
- •No contraindication to general anesthesia for heavy surgery
- •Patient must be informed and the Informed Consent Form signed before any study-specific procedures start.
- •Medical/Public Health insurance coverage
- •Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
- •Performance Status WHO < 2,
- •Previous treatment for epithelial ovarian cancer, tubal peritoneal primitive
- •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)
- •Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix (pegylated liposomal doxorubicine: with gemcitabine, trabectidine, hycamtin authorized)
- •Complete cytoreductive surgery,
- •Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 12 weeks
- •No hepatic insufficiency (bilirubin ≤ 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT ≤ 3 ULN,
- •No renal insufficiency (creatinine ≤ 1.5 ULN, creatinine clearance >60 ml/min) calculated with MDRD method,
排除标准
- •Patient age <18 years,
- •Non-epithelial ovarian tumor,
- •Uncontrolled infection,
- •Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
- •Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
- •Patient who has already been treated by HIPEC for ovarian cancer,
- •Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,
- •Pregnant or breastfeeding woman
- •Patient who has already been enrolled in another clinical trial
- •Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),
- •Known hypersensitivity to cisplatin,
- •Metastasis,
- •Use of anti-angiogenic treatment within 8 weeks before surgery
- •Patient with other concomitant severe life threatening disease,
- •More than 2 segmental resections concomitant to HIPEC is foreseen,
- •Any progressive disease during the second-line chemotherapy (platine-based),
- •Relapse occurring less than 6 months after the end of the initial treatment,
结局指标
主要结局
The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.
The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.
次要结局
- Relapse-free Survival : Relapse-free survival will be defined as the absence of clinical evidence (presence of mass, or effusion with cytological diagnostic), biological criteria (confirmed elevation of CA 125 markers according to RUSTIN criteria) or medical imaging criteria (detection of measurable mass, with the new RECIST criteria). The main criteria will be the date at which relapse occurrence is detected.
- Pain and Quality of Life : Quality of life (QoL) will be studied with the QLQ C30 form from EORTC and FACT O form specific for ovarian cancer (functional assessment of cancer therapy for ovarian cancer). Pain will be evaluated with VAS. History of chronic pain will be noted and accounted for in the analysis.
- Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale
- Morbidity : Morbidity evaluation will be performed until the 60th day after surgery, taking into account: - deaths - severe complications
- Medico-economic study: collection of socio-demographical data and patient management costs.
- Pharmacokinetic study: on 50 patients included who received HIPEC (25 in the open method and 25 in the closed method: Analysis of platinum concentrations at the peritoneal, plasma and tissue levels.
研究者
Nourredine AIT RAHMOUNE
Scientific
Unicancer
研究点 (32)
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