RecruitingInterventional

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

When cancer spreads from the bowel, ovary, or stomach to the lining of the tummy (the peritoneum), standard chemotherapy given through a drip or as tablets often struggles to reach it. The PICCOS trial is looking at a new approach called PIPAC. This technique sprays chemotherapy directly into the tummy during a short keyhole operation. In this study, half of the participants receive the usual chemotherapy offered on the NHS. The other half receive the usual chemotherapy along with the PIPAC spray treatment. Researchers want to find out whether adding PIPAC helps control cancer growth, lengthens life, and improves day-to-day well-being. The trial is open to people aged 16 and over across the UK who are well enough to undergo treatment. The results will help determine if the NHS should routinely fund this treatment.

At a glance

Status

Recruiting

Sponsor

Cardiff and Vale University Health Board

Enrolment target

216

Start

22 Jan 2024

Estimated completion

31 Oct 2027

Colorectal, ovarian and stomach cancer with peritoneal metastasis

What is this study about?

When bowel, stomach, or ovarian cancer spreads, it can reach the peritoneum, which is the thin layer of tissue lining the inside of the abdomen. Doctors usually treat this with chemotherapy given through a vein or taken as tablets. However, medicines in the bloodstream cannot always get deep into the lining of the tummy, and they can cause uncomfortable side effects across the whole body.

To tackle this, doctors have developed a technique called Pressurised IntraPeritoneal Aerosolised Chemotherapy, or PIPAC. During a quick keyhole surgery carried out under general anaesthetic, chemotherapy is turned into a fine spray and applied directly to the cancer spots in the abdomen. Because the medicine is sprayed directly where it is needed, it may treat the cancer more effectively while limiting side effects elsewhere.

PIPAC is used in several countries, but in the UK, it is currently only available through clinical trials. The UK healthcare watchdog, NICE, looked at the early evidence and found that PIPAC could improve how long and how well people live. However, they recommended a large, fair trial to be certain of its benefits before making it widely available on the NHS.

The PICCOS trial compares standard chemotherapy against standard chemotherapy combined with PIPAC. By tracking both groups, researchers at Cardiff University and hospitals across the UK hope to find out whether this new spray treatment truly provides better results and a better quality of life for patients.

Key takeaways

The PICCOS trial is testing a direct chemotherapy spray (PIPAC) for cancer that has spread to the tummy lining.
It is open to people aged 16 and over with bowel, stomach, or ovarian cancer.
Participants are randomly split into two groups: standard chemotherapy alone, or standard chemotherapy plus PIPAC.
PIPAC is carried out using keyhole surgery under general anaesthetic.
Taking part helps doctors gather the evidence needed to decide whether the NHS should fund this treatment permanently.

Who may be eligible?

This trial is open to adults and young people aged 16 and over who have been diagnosed with bowel cancer, stomach cancer, or ovarian cancer that has spread to the lining of the tummy (peritoneum). The cancer spots must be visible on a CT scan.

To take part, you need to be reasonably active and able to look after yourself, such as carrying out light daily tasks. Because both chemotherapy and surgery put demands on the body, your recent blood tests must show that your kidneys, liver, and bone marrow are working well enough to handle treatment safely.

Your cancer care team will check specific details about your previous treatments and your cancer type. For example, people with ovarian cancer can take part if their cancer did not respond to or came back after platinum-based chemotherapy. If you are fit enough for full-dose chemotherapy and can give your informed consent, your doctor can check whether you meet all the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 16 or over.
I have bowel, stomach, or ovarian cancer that has spread to the lining of my abdomen (peritoneum).
My cancer spots can be seen on a CT scan.
I am fairly active and able to manage my day-to-day self-care.
My doctor considers me well enough to have full-dose chemotherapy.

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will randomly place you into one of two groups. You have an equal 50/50 chance of being in either group. One group receives the current standard chemotherapy recommended on the NHS. The other group receives the standard chemotherapy plus PIPAC spray treatments, which are done during keyhole surgery under general anaesthetic.

Throughout the study, you will have regular hospital visits for your treatments, routine blood tests, and CT scans to monitor your health and see how the cancer is responding. You will also be asked to fill out simple questionnaires about how you are feeling and your overall quality of life. The study runs over several months, and the team will follow your progress until the trial concludes in late 2026.

Potential risks and benefits

Taking part may give you access to a new treatment that could help slow cancer growth, improve quality of life, and help you live longer. Even if you are not selected for PIPAC, you will receive high-quality standard NHS care and will help doctors discover better treatments for future patients. However, treatments do involve risks. Standard chemotherapy can cause tiredness, nausea, and a higher chance of infection. PIPAC also carries the usual risks of keyhole surgery and general anaesthetic, such as mild pain, bruising, or short-term tummy discomfort. Taking part is completely voluntary, and you can change your mind and leave the study at any time without it affecting your ongoing NHS care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cardiff & Vale UHB
City only
Cardiff, Wales
Imperial College Healthcare NHS Trust
City only
London, England
Swansea NHS Trust
City only
Swansea, Wales
Royal United Hospitals Bath NHS Foundation Trust
City only
Bath, England

Common questions

What is PIPAC?

PIPAC stands for Pressurised IntraPeritoneal Aerosolised Chemotherapy. It is a method of spraying chemotherapy directly inside the tummy during a keyhole operation so it can reach cancer on the tummy lining directly.

Can I choose to have the PIPAC treatment?

No. A computer randomly decides who receives PIPAC alongside standard chemotherapy and who receives standard chemotherapy alone. This random choice is essential to ensure the study results are fair and reliable.

Will I have to stay overnight in hospital for PIPAC?

PIPAC involves a short keyhole procedure under general anaesthetic. Most people need only a brief hospital stay, often going home the same day or the following day, depending on how quickly they recover.

What happens if I do not get PIPAC?

You will receive the standard NHS chemotherapy that is considered the best available treatment for your condition. Your care will be monitored just as closely by the medical team.

Do I have to pay anything to take part?

No. The trial is funded by the National Institute for Health and Care Research (NIHR) and all study treatments and tests are provided free of charge through the NHS.

How to find out more

Catherine Green

research.governance@wales.nhs.uk +44 (0)29 2074 3301 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.