PICCOS
Research type
Research Study
Full title
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. PICCOS
IRAS ID
1006905
Contact name
Maureen Edgar
Contact email
Sponsor organisation
Cardiff and Vale University Health Board
Eudract number
2022-003680-26
ISRCTN Number
ISRCTN17575409
Research summary
Bowel, ovarian and stomach cancer will often spread (metastasise) to the lining (peritoneum) of the abdominal cavity. This trial aims to determine if a new way of delivering chemotherapy as a spray, directly into the peritoneal cavity, would improve survival in patients with peritoneal metastases, compared to conventional intravenous chemotherapy. Critically, we will also assess the impact of treatment on patient quality of life.
Up to 13%, 50% and 14% of patients with bowel, ovarian and stomach cancer respectively, present with peritoneal metastases. When this form of spread occurs, patients are normally informed that their disease is incurable. As well as a relatively rapid decline, peritoneal metastases can cause a series of unpleasant symptoms due to new tumour growth. Peritoneal metastases are difficult to treat with conventional anticancer drugs and there is an urgent need to develop new treatment strategies. A new strategy showing potential is Pressurised IntraPeritoneal Aerosol Chemotherapy (PIPAC). PIPAC delivers anti-cancer drugs into the peritoneal cavity as an aerosol during keyhole surgery. PIPAC has been shown to deliver higher doses of chemotherapy directly to tumour sites compared to conventional treatment, with fewer side-effects due to less chemotherapy circulating in the blood. PIPAC has been shown to be both safe and feasible in a series of clinical trials. The question that now remains is whether PIPAC is effective or not. NICE has recommended that PIPAC should only be offered to UK patients within a research trial setting.
This randomised controlled trial will be open to patients with bowel, ovarian or stomach cancer. 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 to receive either standard chemotherapy or a combination of standard chemotherapy and/or PIPAC, where 3 PIPAC procedures are performed.
REC name
Wales REC 5
REC reference
23/WA/0159
Date of REC Opinion
14 Sep 2023
REC opinion
Further Information Favourable Opinion