Pilot Study of Adjuvant Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for the Prevention of Peritoneal Metastases After Curative-intent Surgery for High-risk Colorectal Cancer.
The objective of this clinical trial is to demonstrate the feasibility and safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.
• Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection);
• curative (microscopically complete) surgery performed by laparotomy or laparoscopy;
• presence of at least one of the following risk factors for the development of metachronous peritoneal metastases:
‣ perforated primary tumor (any T, N0-2b, M0);
⁃ primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0), or directly invading adjacent organs (pT4b, N0-2b, M0);
• age \> 18;
• performance status 2 according to the World Health Organization score;
• willingness to start adjuvant systemic chemotherapy and post-operative follow-up;
• Signing of informed consent.