Article Text
Abstract
Introduction Up to 13%, 50% and 14% of patients with bowel, ovarian and stomach cancer respectively, present with peritoneal metastases (PM) which is difficult to treat with conventional chemotherapy. Pressurised IntraPeritoneal Aerosol Chemotherapy (PIPAC) which delivers chemotherapy into the peritoneal cavity, directly to the tumour site, as an aerosol during keyhole surgery is emerging as a potential new strategy. This trial aims to determine if PIPAC given with (colorectal, stomach) or instead of (ovarian) systemic anti-cancer therapy (SACT) improves Peritoneal Progression Free Survival (pPFS) compared to standard SACT.
Methods PICCOS trial (PIPAC In Cancers of the Colon, Ovaries and Stomach) is a multi-arm, prospective randomised controlled trial (RCT) in the UK designed to provide high quality evidence regarding the efficacy of PIPAC in improving pPFS. Each cancer type will have individual eligibility criteria and protocols to allow for the necessary variations in treatment. In all cancer types, patients will be randomised in a 1:1 ratio to receive either standard SACT or a combination of standard SACT and/or PIPAC, where three PIPAC procedures are performed. We aim to recruit 78 colorectal, 66 ovarian and 72 stomach cancer patients over 2.5 years and follow-up will last for a minimum of 6 months.
Current Trial Status This is the largest RCT in the world that is investigating the efficacy and impact on quality of life of PIPAC in the treatment of PM. PICCOS aims to provide high quality evidence to guide clinical practice and further research. The trial is currently recruiting.