Evaluation of Molecular and Pathophysiological Mechanisms of Peritoneal Carcinomatosis and Monitoring of the Efficiency of PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) as a Local Chemotherapeutical Treatment.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall Survival (years)
研究概览
简要总结
The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors
- •Age > 18 years
- •signed informed consent
排除标准
- •Patient can not understand meaning and purpose of the study
结局指标
主要结局
Overall Survival (years)
时间窗: 5 years
次要结局
- Quality of lfe questionnaire (EORTC QLQ-C15-PAL)(5 years)
- The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments(25 weeks)
- Overall Response Rate (CT RESIST criteria)(5 years)
研究者
Dr. Boris Jansen-Winkeln
Dr. B. Jansen-Winkeln and Prof. Dr. I. Gockel
University of Leipzig