Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC) in the management of cancers of the bowel, ovary and stomach: a randomised controlled trial of efficacy in peritoneal metastases

ABSTRACT: Background and study aims Patients with peritoneal metastases normally receive chemotherapy or biological medications either through a drip (intravenously) or by taking it in tablet form, or through combinations of these. Chemotherapy and biological medications are both types of systemic anti-cancer therapy (SACT). Even with the usual chemotherapy, peritoneal metastases can be difficult to manage as chemotherapy medicines that circulate in the bloodstream do not reach the peritoneal metastases very well and cause many side effects by acting on other areas of the body that can affect a patient’s quality of life. New more effective and less severe ways of managing peritoneal metastases are urgently needed. This trial aims to find out whether using a new treatment strategy to deliver chemotherapy as a spray directly into the abdominal cavity during keyhole surgery is better at managing peritoneal metastases than the usual chemotherapy. This new way of giving chemotherapy is called Pressurised IntraPeritoneal Aerosolised Chemotherapy or PIPAC for short. It has been used across the world for a few years, however, it has only been allowed in the UK as part of research studies. The National Institute for Health and Care Excellence (NICE) reviewed the evidence for PIPAC in 2021. It found that while patients who had PIPAC may have improved survival and quality of life, higher quality evidence was needed before a decision can be made on whether or not to approve it being available to patients on the NHS. The best way of knowing whether one treatment is better than another is by carrying out a type of research called a randomised controlled trial (RCT). An RCT is a type of research study in which patients are randomly allocated into two groups - an experimental group that receives the new treatment and a control group that receives the usual treatment. Patients have an equal chance of being allocated to the experimental or control group. This enables a fair comparison to be made to see which treatment works best. Who can participate? Patients aged 16 years old and over with visible (measurable or non-measurable) peritoneal lesions What does the study involve? Because of the NICE recommendations, researchers designed the PICCOS trial – this is an RCT. Half of the patients in this trial will receive their usual chemotherapy, whilst the other half have their usual chemotherapy in addition to chemotherapy given by PIPAC. The PICCOS trial also aims to find out whether there are differences in the quality of life in patients with peritoneal metastases who have PIPAC compared to those who do not.

DISEASE(S): Colorectal,Ovarian And Stomach Cancer With Peritoneal Metastasis

PROVIDER: 93152 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR