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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.

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 usual chemotherapy, peritoneal metastases are difficult to manage as chemotherapy medicines that circulate the bloodstream do not reach the peritoneal metastases very well and cause many side effects 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 delivering chemotherapy is called Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC for short). It has been used across the world for several 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. They 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 as an NHS treatment.

The most effective way to scientifically know whether one treatment is better than another is to carry 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 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. This RCT will then allow for PIPAC to be compared against standard chemotherapy treatment for patients with peritoneal metastases in colorectal, ovarian and stomach cancer.

Key facts

Start date 1 Nov 2022
End date 31 Oct 2026
Grant value £1,940,674
  • Recruiting

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