Introduction/Background In 2021 the National Institute for Clinical Excellence (NICE) published interventional procedures guidance stipulating that in the UK, Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC) should only be used within the context of a randomised control trial to demonstrate efficacy against standard of care. The UK PIPAC collaborative would like to present its first randomised controlled trial assessing the efficacy of PIPAC in the management of peritoneal metastases (PM) in patients with cancer of the colon, ovary and stomach. The PICCOS trial aims to not only assess efficacy compared to standard of care in terms of progression free survival (PFS), but also quality of life.
Methodology This is a basket, phase II trial with a master protocol covering the overarching research methodology, and embedded individual cancer site specific protocols, sample sizes and analysis plans. 78 patients with PM from colon cancer, 62 patients with PM from ovarian cancer and 72 patients with PM from stomach cancer will be randomised to systemic chemotherapy or alternating PIPAC and systemic chemotherapy every 2 or 3 weeks for 18 weeks in total. The primary outcome measure is PFS. CT scans undertaken every 8 weeks following treatment will be assessed against the RECIST criteria to assess disease burden and determine PFS. Quality of life will be assessed using the EORTC QLQ C30 tool.
Results The PICCOS Trial has now secured funding with a National Institute of Health Research Efficacy and mechanism Evaluation (NIHR EME) grant and is due to commence in November 2022 with a four year running period. Publication and dissemination of results is anticipated in 2027.
Conclusion This is the first UK randomised controlled trial assessing the efficacy and impact of quality of life of PIPAC in the treatment of peritoneal metastases aiming to provide high quality evidence to guide clinical practice and further research in the future.
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