Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Progression Free survival
研究概览
简要总结
Peritoneal metastasis is a common pattern in advanced gastric cancer leading to a terminal condition in a very short time. Whatever recent progress regarding systemic chemotherapy using multi drugs association median survival is limited to 6 months with altered quality of life (QoL) after 4 months for all patients. We postulated that a new innovative health technology for delivering intraperitoneal pressurized aerosol of chemotherapy (Doxorubicin and Cisplatin) during laparoscopy can transform that situation offering to double the survival with QoL preservation. Interestingly, PIPAC procedure is made to be applied repeatedly, every 4 to 6 weeks. This therapeutic strategy allows to improved Intra Peritoneal (IP) drugs impregnation and maintained Intra-Veinous (IV) chemotherapy meanwhile. The primary objective of this study is to evaluate and compare 24-month progression free-survival in patients with peritoneal carcinomatosis of gastric cancer treated either with IV chemotherapy and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) or with IV chemotherapy alone, with preservation of quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 < age ≤ 75 years
- •Performance status (WHO) < 2
- •White blood cells > 3.500 /mm3; neutrophils > 1.500 /mm3; platelets > 100.000 /mm3
- •Creatinemia < 1.5 x Normal, Normal ASAT, ALAT and Serum total bilirubin, Normal ionic balance (potassium, calcium, magnesium and phosphorus
- •An acceptable nutritional condition with Body Mass Index (BMI) > 18.5 kg/m2, Albumin > 30 g/l, pre-albumin > 110 mg/l
- •Effective contraception for patients of childbearing age
- •Written consent obtained prior any act of the research
- •Patient with social insurance
- •Patient having synchronous or metachronous peritoneal metastasis or ovarian metastasis of a gastric adenocarcinoma cancer, including adenocarcinoma with independent cells (ADCI) or linitis
- •Patients with or without primary gastric tumor could be included
- •Peritoneal Cancer Index (PCI) > 8
排除标准
- •Weight loss > 20% of total body weight before disease
- •Presence of uncontrolled comorbidities including severe chronic disease or organ insufficiency
- •Contraindication to any drug contained in the chemotherapy regimen, according to summary of product characteristic's
- •Having any form of previous intra-abdominal chemotherapy or intra-abdominal antibody therapy
- •Patients with history of allergic reactions to platinum compounds or doxorubicin
- •Complete deficiency of the enzyme dihydropyrimidine dehydrogenase.
- •Patients are not allowed to undergo any cancer-specific treatment during the trial.
- •Secondary debulking surgery is not allowed during PIPAC treatment
- •Pregnancy or breastfeeding
- •Patient under guardianship
- •Other systemic metastases (liver, lung, bone, brain) or lombo-aortic lymph node involvement
- •Pleural effusion requiring evacuation for respiratory failure
- •Small bowel occlusion with no possible food intake
- •Ascites > 3 liters
- •HER2 +++ tumor
研究组 & 干预措施
Control Arm
干预措施: Standard chemotherapy (Drug)
Experimental Arm : PIPAC
干预措施: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) (Drug)
结局指标
主要结局
Progression Free survival
时间窗: 24 months
24-month progression free-survival, defined as time from randomization to any clinical (ascites, abdominal pain, weight loss \> 10% of total body weight) and/or morphological signs (systemic metastases, ascites, progression with RECIST criteria) of recurrence (local or systemic) or death.
次要结局
- Postoperative pain H12(12 hours after end of surgery)
- Toxicity(60 days)
- Quality of life(monthly until death or 24 months)
- PIPAC success(24 hours)
- Morbidity Clavien-Dindo(60 days)
- Postoperative pain H6(6 hours after end of surgery)
- Postoperative pain H18(18 hours after end of surgery)
- Postoperative pain H36(36 hours after end of surgery)
- Postoperative pain H42(42 hours after end of surgery)
- Postoperative pain H48(48 hours after end of surgery)
- Overall survival(24 months)
- Quality of health status(monthly until death or 24 months)
- Discontinuation(24 months)
- Postoperative pain H24(24 hours after end of surgery)
- Postoperative pain H30(30 hours after end of surgery)
- Secondary resectability rate(24 months)
- Morbidity Complication Index(60 days)