A Welsh-led clinical trial hopes to provide the evidence needed to introduce a new type of chemotherapy for ovarian cancer.
More women die from ovarian cancer than all other gynaecological cancers combined, and Wales has one of the highest rates of the disease in the UK. Treatments are limited, especially as more than two thirds of women are diagnosed with late-stage disease which can become resistant to treatment. 51% of women in Wales diagnosed in stage 4 will not survive for a year.
The PICCOS trial, led by chief investigators Dr Sadie Jones and Professor Jared Torkington and supported by Cardiff’s University’s Centre for Trials Research and Cardiff and Vale University Health Board, aims to answer important questions about a new mode of anti-cancer drug delivery, Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC). The trial is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC), with contributions from the Chief Scientist Office in Scotland, Health and Care Research Wales and the Health and Social Care R&D Division, Public Health Agency in Northern Ireland.
Advanced ovarian cancer can spread (metastasise) to the lining of the abdomen (peritoneum), leading to abdominal pain, weight loss and bloating. Standard chemotherapy medicines that circulate through the bloodstream struggle to reach peritoneal metastases effectively, and cause side effects that can significantly affect a patient’s quality of life.
PIPAC delivers chemotherapy drugs directly as an aerosol during keyhole surgery. It has been shown to deliver higher doses of chemotherapy drugs directly to tumour sites, with fewer side effects.
PIPAC has been used in other countries for several years but has only been allowed in the UK as part of research studies. The PICCOS trial aims to provide the high-quality evidence required to approve PIPAC as an NHS treatment for ovarian and, potentially, stomach and colorectal cancer.
Dr Jones was supported with time to develop the trial with a Health and Care Research Wales Research Time Award. She said, “This is the UK’s first randomised controlled trial to compare PIPAC against standard chemotherapy treatment for patients with peritoneal metastases, to assess whether it improves survival rates and quality of life for patients. These tumours are very difficult to treat, meaning new, more effective and less severe ways of treating peritoneal metastases are urgently needed. Evidence about whether this treatment is effective is paramount to decipher whether it should be brought into standard practice.
“Ovarian cancer is the biggest cause of peritoneal metastasis of all cancers, but this trial will also assess its impact in patients with stomach and colorectal cancer.
“There is a huge amount of interest in this trial and how it may inform where this type of treatment goes in the future. While it is challenging to deliver, the potential impact could be huge.
“While the main aim is to slow cancer progression and improve quality of life, we also hope in time to be able to offer it at an earlier stage, where it could potentially contribute to improved survival rates.”
Professor John Simpson, Director of the NIHR/MRC EME Programme, said: “It’s essential that we fund studies like this to help researchers to discover whether different methods of treatment for illnesses like ovarian cancer can be more effective than the options available currently.
“Not only can these trials identify vital evidence to help inform future practice, they can also lead to better outcomes for patients.”
