PICCOS: study protocol for pressurised intraperitoneal aerosolised chemotherapy (PIPAC) in the management of cancers of the colon, ovary and stomach: a randomised controlled, phase II trial of efficacy in peritoneal metastases

Abstract Objectives Peritoneal metastases (PM) represent a significant unmet need requiring urgent development of treatment options to improve patient prognosis and quality of life (QoL). A novel anti-cancer technology is Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC). PIPAC aims to improve target specificity of anti-cancer therapies by delivering medication as an aerosol directly to the peritoneum at laparoscopy. Early phase I/II studies suggest that PIPAC has the potential to improve treatment efficacy and cancer outcomes whilst maintaining or improving QoL through less systemic drug absorption. PICCOS aims to determine whether PIPAC can improve peritoneal progression free survival (pPFS) in patients with PM from, compared to SACT alone. Methods PICCOS is a phase II, multi-centre, superiority, randomised controlled trial (ISRCTN 17575409). It aims to determine whether PIPAC (given alone or in combination with systemic anti-cancer therapy (SACT)) can improve peritoneal progression free survival (pPFS) as per RECIST (V1.1) in patients with PM, compared to SACT alone. Key secondary outcome measures include quality of life, safety, overall survival and progression free survival. 216 patients with non-resectable PM from colorectal cancer, platinum resistant ovarian cancer and gastric cancer will be recruited. Patients will be randomised to receive either standard of care SACT alone or PIPAC in combination with (colorectal, gastric groups) or without (ovarian group) standard of care SACT. Median pPFS will be estimated using the Kaplan–Meier method. The log-rank test, stratified by prognostic factors, will be used to compare PFS distributions. Results PIPAC is expected to achieve improved peritoneal progression free survival for patients in comparison to those treated with standard care. Conclusions PICCOS aims to provide much needed, high-quality evidence on the efficacy of PIPAC in treating PM.