Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study : OPAC Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Progression free survival
研究概览
简要总结
Colorectal cancer is the third most common cancer in men and second in women. It represent 345'346 new cases per year in Europe and 134'349 in the United States of America. The peritoneal cavity is the second most frequent site, after liver, for colorectal cancer relapse.Peritoneal carcinomatosis (PC) is found in approximately 5 % of patients diagnosed with colorectal cancer and 24% of patients with synchronous metastasis at the time of diagnosis. Eight percent of colorectal cancer patient will develop PC during the course of their disease .
Currently systemic chemotherapy is the standard of care for the treatment of unresectable peritoneal carcinomatosis from colorectal cancer with a median survival rate of 16.3 months Peritoneal carcinomatosis has a poor response to systemic chemotherapy due to a weak penetration of agents into the peritoneum.
A new approach of intraperitoneal carcinomatosis is now developed: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is used to deliver intraperitoneal chemotherapy. It enhances the effect of chemotherapy because of the physical properties of aerosol and pressure.
PIPAC is a safe with a 23% morbidity and tolerated technic that is now well described.
We want to conduct a study to prove or infirm the superiority of PIPAC associated with systemic chemotherapy compare to systemic chemotherapy alone in peritoneal carcinomatosis from colorectal cancer
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
- Single (Participant)
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
- •Patients 18 < age ≤ 75 years old with Performance status (WHO) ≤ 2 Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI ≥ 15 (No complete resectable PC) Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI < 15 + liver or pulmonary unresectable metastases PCI < 15 but with progression at the restaging after the first line of chemotherapy Unresectable peritoneal relapse secondary to cytoreduction surgery
排除标准
- •Patients with clinically significant ascites (> 3000 cc)
- •Pleural effusion requiring evacuation for respiratory failure
- •Small bowel occlusion with no possible food intake
- •Presence of comorbidities, notably serious chronic diseases or organ failure
结局指标
主要结局
Progression free survival
时间窗: 8 months
any clinical sign and/or morphological sign of peritoneal recurrence or death
次要结局
- Quality of life C30(8 months)
研究者
Sleiman Marwan-Julien
Doctor
University Hospital, Geneva