International ‘FOxTROT’ bowel cancer clinical trials open at centres across Yorkshire

Hundreds of newly diagnosed bowel cancer patients in Yorkshire will have the opportunity to take part in two international clinical trials following £3.4 million in funding from Yorkshire Cancer Research.

Led by researchers at the University of Leeds and the University of Birmingham, the new studies will explore whether giving specific groups of patients a course of chemotherapy before surgery can help improve survival rates.

Recruitment is now open at Calderdale and Huddersfield NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust, with a further six centres in Yorkshire to follow soon.

Dr Jenny Seligmann, chief investigator of the trials and consultant medical oncologist at the University of Leeds said: “The new trials will save lives and improve the experience of patients in Yorkshire. As well as providing an opportunity to take part in research, which is known to improve survival rates, the trials will help bring gold-standard treatment to participating hospitals.”

Every year in Yorkshire, 3,500 people in Yorkshire are diagnosed with bowel cancer and nearly 1,300 people lose their lives. Patients are usually treated with surgery first and may go on to have chemotherapy afterwards to help stop the cancer coming back.

However, a study called ‘FOxTROT 1’ found that giving six weeks of chemotherapy before an operation was safe for patients and led to fewer serious complications following surgery.

The research also discovered that for many patients, the chemotherapy shrank the tumour, potentially making surgery less complex. It also found that the cancer returned in fewer patients, improving survival rates.

The FOxTROT 1 trial involved more than 1,000 patients across the UK, Denmark and Sweden and the new approach to treating bowel cancer has since become a treatment option under NICE (the National Institute for Clinical Excellence) guidelines.

Now, with funding from Yorkshire Cancer Research, the researchers behind that trial are hoping to build its success by exploring the approach in a wider group of patients.

FOxTROT 2 will test if the approach works in older, frailer patients. FOxTROT 3 will investigate whether a more extensive chemotherapy can further improve benefits in patients who can tolerate more intensive treatment.

The trials are being supported by Pete Wheatstone from Selby, who was diagnosed with bowel cancer in 2014 and now provides a patient perspective for research teams.

Pete, 66, said: “FOxTROT is a bowel cancer trial, so it’s very close to my heart. I was treated with surgery followed by chemotherapy. If I’d had the opportunity to take part in research like this when I was diagnosed, it might have helped me. I’m hopeful that the trials will bring more benefits to patients, and lead to less chance of the cancer coming back, which as a cancer patient is always the worst thing. Even now, in the dark hours of the early morning, that thought in the back of my mind returns.

“New treatments, whether they are new drugs or processes, come about through research, and research is expensive. It’s important that these studies are funded by medical charities like Yorkshire Cancer Research. That’s why I contribute to the charity; because I want to say thank you for the treatment I received, but I also want to make it better for future patients.”

Dr Seligmann, who is based at the Bexley Wing at St James’s University Hospital in Leeds said: “Introducing this approach has been one of the biggest advances in the last 15 years for this common cancer. For the first time we will be able to start personalising therapy by selecting the right treatment for the right patient. The new research will allow us to further define which patients are suitable for chemotherapy and who will respond best to this approach.”

Also leading the trial is Professor Dion Morton, Barling Professor of Surgery at the University of Birmingham. He said: “Colon cancers are occurring more frequently year on year and already account for one in 14 cancer deaths worldwide. The FOxTROT collaboration involves partners from three continents and has the potential to reduce death and harm from colon cancer across the world.”

Dr Stuart Griffiths, Director of Research at Yorkshire Cancer Research said: “Yorkshire Cancer Research funds work that has a direct impact right here in the region. Our aim is to save 2,000 lives from cancer every year in Yorkshire, and we bring pioneering trials and world-leading research to the region to help achieve this."

“If successful, the findings from the trial can quickly be incorporated into normal clinical practice, meaning this research could have an impact on patients straight away. As a result, more people will survive bowel cancer right now, rather than 20 or 30 years down the line.”

The University of Leeds is the sponsor for the trials, with co-ordination by the Clinical Trials Research Unit.

Dr David Cairns, Director of Late Phase Trials in the Cancer Division at the Clinical Trials Research Unit at Leeds, said: “Clinical trials are important because they provide gold-standard evidence to say if a new treatment should be used in the NHS. Participants in a trial might get a new treatment, or a change in the way existing treatments are delivered as in the case of FOxTROT, before it is available to everyone, but even if not, they play a more active role in their own health care with a clear treatment plan described from the start.

“Evidence suggests that clinical trial participants do better than those outside of clinical trials, perhaps through being carefully monitored at research-active hospitals. Bringing world-leading, scientifically rich clinical trials to Yorkshire brings the opportunity to discover the tests and treatments of the future. We are excited to be opening FOxTROT in many of our Yorkshire hospitals giving the opportunity for more patients in our region to benefit from these important clinical trials.”