Singleton Hospital leads rectal cancer trial that could transform treatment worldwide

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A major clinical trial spearheaded in Swansea could change the way cancer patients around the world are treated.

Singleton Hospital-based consultant Dean Harris is leading the UK-wide study involving the treatment of rectal cancer.

Singleton team

The Singleton team (l-r): consultant surgeon Professor John Beynon, consultant clinical oncologist Olivia Hatcher, Professor Dean Harris

Current guidelines suggest certain patients should have a course of radiotherapy – which can have a devastating impact on a patient’s quality of life – to shrink the tumour before it is surgically removed. But now advances in tumour imaging and surgical techniques mean it may not be as necessary to have this additional treatment.

Professor Harris said:

“The ultimate aim is to change current guidelines as to who should and shouldn’t have radiotherapy, because there is uncertainty at the moment.

“Some patients with advanced disease will still require it where complete surgical removal cannot be guaranteed.

“However, we have found that not every patient needs it for a good outcome, especially given the long-term side-effects.”

Dean Harris

Professor Harris (pictured), consultant colorectal surgeon at Singleton and honorary clinical professor at Swansea University, is the study’s chief investigator.

The trial involves Singleton Hospital, Swansea University, St Mark’s Hospital, London, St Vincent’s University Hospital, Dublin, Western General Hospital, Edinburgh, and Betsi Cadwaladr Cancer Treatment Centre in Rhyl.

Funded by UK national charity the Bowel Disease Research Foundation, the trial will look at locally advanced rectal cancer - where the tumour is large but may not have spread. It’s where the cancer is close to the limit of surgical removal, or where there is lymph gland involvement.

There are more than 14,000 newly diagnosed rectal cancers in the UK every year, 40 per cent of them locally advanced.

NICE (National Institute for Health and Care Excellence) guidelines recommend patients to have radiotherapy ahead of surgery.

However, the experience of Singleton and other centres worldwide is that this is not always necessary.

Professor Harris said:

“There are major long-term problems during and after radiotherapy, such as chronic pain, sexual dysfunction, bowel and bladder problems, and there is a cost implication.

“Even when the disease is locally advanced, we prefer to perform a high quality operation without radiotherapy, ensuring the entire tumour is removed.

“We have published very good cancer outcomes with this approach. We consider radiotherapy isn’t as necessary as NICE guidelines suggest.”

Each year, rectal cancer treatment outcomes are published in the Welsh Bowel Cancer Audit. Swansea’s results consistently show the highest rate of complete tumour removal despite the lowest use of radiotherapy.

Professor Harris and his colorectal team colleagues in Singleton published their findings in the British Journal of Surgery this year.

Essentially, the survival rate and rate of recurrence of cancer in the pelvis area was the same for patients who did not have radiotherapy as it was for those who did.

Professor Harris said:

“The colorectal unit has taken this approach for 10-15 years, as pioneered by its founders Professor John Beynon and Nick Carr.

“The recent work we have published cements our ideas and suggests the way we are doing it is correct.

“With a global thrust to try to reduce the amount of radiotherapy, the time is right for a UK-wide trial to test it in rigorous fashion.”

The trial, expected to start early next March, involves recruiting 80 patients across the study sites over two years.

They will be randomly allocated to either surgery only or radiotherapy and surgery, then followed up for a further two years.

Professor Harris said:

“We will analyse the survival and recurrence rate, quality of life, which is thought to be lower if they have radiotherapy, surgical complications and cost.

“Depending on the results we hope it will lead to a much wider global collaborative study. The ultimate aim is to change the guidelines for radiotherapy around the world.”

The research has been endorsed by and developed with the National Cancer Research Institute. It is being funded by a £124,302 grant from the Bowel Disease Research Foundation.

Martyn Hall

BDRF Director Martyn Hall (pictured ) said:

“The BDRF is committed to funding the very highest quality colorectal research projects across the UK and Ireland.

“We are delighted to fund this groundbreaking study, which could lead to important changes to the way rectal cancer patients are treated in the future.

“We would like to pay tribute to our donors and supporters, whose generosity enables research like this to take place and makes a real and lasting difference to the lives of people with bowel disease.”

Professor Harris added:

“It’s a very exciting time. It has taken two years to put the study together and get the team we need to deliver it from the different sites.

“I am delighted we have had funding from the BDRF to take it forward.

“It will help raise ABMU’s profile and demonstrate the high quality surgery we have been doing here for a consistent period of time.”

For further information about the BDRF, go to: www.bdrf.org.uk

Established in 2004, Swansea University’s College of Medicine is an internationally-recognised centre of excellence in medical research, education and innovation. The College of Medicine delivers a comprehensive education and training portfolio, from undergraduate and postgraduate programmes in medicine and life sciences, to professional graduate training and research. It also works closely with its NHS partners in achieving excellence in teaching, research and clinical service. Visit one of the UK’s fastest growing medical schools at http://www.swansea.ac.uk/medicine/.

 Abertawe Bro Morgannwg University Health Board covers a population of approximately 500,000 people and has a budget of £1.3 billion. The Health Board employs around 16,500 members of staff. ABMU has four main hospitals providing a range of services; these are Singleton and Morriston Hospitals in Swansea, Neath Port Talbot Hospital in Port Talbot and the Princess of Wales Hospital in Bridgend. The Health Board acts as the service provider for Wales and the South West of England in respect of Burns and Plastic Surgery. There are more than 300 GPs, 275 dentists, 125 Community Pharmacies and 60 Optometry premises across the Health Board area.