A pioneering clinical trial funded by Yorkshire Cancer Research has shown a promising new approach to radiotherapy that could improve the effectiveness of treatment for people with rectal cancer who are unable, or choose not, to have surgery.

The APHRODITE trial, jointly led by Professor Ane Appelt at the University of Leeds and Professor Simon Gollins at the North Wales Cancer Treatment Centre and Bangor University, explored whether giving people a higher dose of radiotherapy, compared to the current standard treatment, can increase the likelihood of the cancer disappearing completely, without causing significant additional side effects.

Early findings from the study, presented for the first time at a major European conference in May, showed more people receiving the higher dose of radiotherapy had no visible cancer six months after completing treatment, suggesting this approach could offer better treatment while maintaining a similar quality of life.

Most people diagnosed with early-stage rectal cancer will have surgery to remove the rectum. However, some people are unsuitable for surgery as they have other health conditions which increase the risk of serious complications from the surgery. For others, living with a stoma bag (bowel bag), which may be needed temporarily or permanently after surgery, could have too great an impact on their day-to-day life.

For these groups, radiotherapy or ‘chemoradiotherapy’ - where radiotherapy is given alongside chemotherapy – can be offered. Treatment is typically delivered over five and a half weeks.

Currently, around a third of people who receive this standard chemoradiotherapy approach will have no visible signs of cancer six months after treatment. The APHRODITE trial tested giving people a higher dose of radiotherapy over the same period and saw the proportion of people with no visible signs of cancer after six months increase to almost a half.

Additionally, despite receiving a higher dose of radiotherapy, most people reported low levels of side effects and were able to experience their usual quality of life within six months of treatment. This offers an important option for people who are unable to tolerate more intensive treatment such as surgery, providing them with a gentler yet still effective alternative.

Delivered by the University of Leeds Clinical Trials Research Unit, a total of 119 people took part in the trial, including from Leeds, Sheffield and York, as well as other regions across the UK. They will continue to be monitored to understand whether this approach can help prevent cancer from coming back and support quality of life over the longer term. Early analysis has provided the first insight into how this approach could improve treatment and pave the way for further research across the UK.

People who take part in clinical trials play a vital role in the advancement of cancer research, helping researchers determine whether new technologies and treatments can be used to treat and save lives in the future. More than 120,000 people in Yorkshire have had the opportunity to take part in clinical trials funded by Yorkshire Cancer Research.

One of those people is Christine Skinner from York, who took part in the APHRODITE trial and received treatment at Leeds Cancer Centre after being diagnosed with rectal cancer in early 2024.

A retired professor and former nurse and midwife, Christine sought medical advice from her GP after noticing mucus and changes to her bowel habits. Further investigations, including a colonoscopy, biopsy and scans, confirmed she had rectal cancer.

Christine said: "I remember walking into the hospital with my friend feeling incredibly nervous. When I was told the cancer had spread to my lymph nodes, I was frightened. Like many people, I immediately started questioning myself. You wonder whether you should have acted sooner, even though my symptoms weren't the more commonly recognised signs of rectal cancer, such as bleeding.”

After discussing surgery, its potential side effects and impact on her quality of life, including the possibility of living with a temporary or permanent stoma bag, Christine decided surgery wouldn’t be the right option for her and signed up to take part in the APHRODITE trial.

Christine received the higher dose of radiotherapy being tested in the study and underwent treatment at St James's University Hospital in Leeds. Throughout the trial, she was supported by specialist clinical and research teams and closely monitored to assess both her response to treatment and quality of life. She experienced very few side effects until the end of her treatment, when she developed some mild skin reactions and increased bowel movements, which resolved shortly after her radiotherapy finished.

Christine said: "Other than physically going to the hospital each day for radiotherapy, I wouldn't really have known I was undergoing cancer treatment. The only side effects I experienced came towards the end of my treatment, but they were soon resolved.

Plus, the level of care was exceptional. From the administrative staff through to the nurses, radiographers and research team, everyone was outstanding. I always felt supported and reassured, and it made me incredibly proud of the NHS."

Now, two years after completing treatment, tests continue to show no evidence of cancer and Christine has been able to continue travelling, spending time with her family and enjoying an active retirement without undergoing major surgery. She will continue to have regular scans to hopefully confirm the cancer has not returned.

Christine said: "I've had as normal a quality of life as I could possibly have hoped for. My cancer diagnosis hasn't stopped me travelling, exercising or doing the things that matter to me. I’ve just welcomed a grandchild into the world and can be an active hands-on grandma thanks, in part, to this trial. I feel incredibly lucky.”

She concluded: "If I'd been diagnosed 10 years earlier, my treatment options might have looked very different and the opportunity to take part in a clinical trial like APHRODITE may not have existed. The boundaries are being pushed all the time and that's because of research taking place here in Yorkshire. I'm incredibly grateful I had the opportunity to take part. It happened at exactly the right time for me, and it has made a huge difference to my life.”

Yorkshire Cancer Research is funding £75m of cancer research and services, including 26 clinical trials, which are finding new and better ways to prevent, detect and treat cancer. These life-giving medical breakthroughs are helping more people survive cancer – in Yorkshire and beyond. The charity works with 750 researchers and cancer experts, bringing vital expertise and knowledge to the region.

This includes Professor Ane Appelt, co-lead of APHRODITE, whose pioneering work on the trial was made possible by a Yorkshire Cancer Research fellowship awarded to her in 2016.

Professor Ane Appelt, Visiting Professor in Radiotherapy Physics at the University of Leeds, said: "APHRODITE has helped us explore whether we can enhance radiotherapy treatment for people with rectal cancer, helping to ensure those for whom surgery is not an option can still benefit from innovative treatment while maintaining their quality of life. The trial was developed in response to challenges we were seeing in clinical practice and the needs of people affected by cancer in Yorkshire.

“We worked closely with people with cancer to shape the trial, from designing information materials to improving communication throughout the study. Their insights helped ensure the research remained focused on the needs and issues that matter most to people undergoing cancer treatment.

“This work was able to happen thanks to support from Yorkshire Cancer Research, which gave me the time and freedom to pursue new ideas and develop research at the University of Leeds alongside my clinical responsibilities at St James’s University Hospital. Yorkshire is an incredibly diverse region, so it is vital that research happens here so we can generate evidence and find pioneering medical solutions to have the greatest impact on communities here. Ultimately, research is about finding better ways to improve lives after a cancer diagnosis, and the support of Yorkshire Cancer Research has been instrumental in making that possible."

Dr Simon Gollins, Co-lead of APHRODITE and Consultant in Clinical Oncology at North Wales Cancer Treatment Centre, added: “In the APHRODITE trial we saw higher rates of tumour disappearance with a small increase in side effects. This is an important step towards offering treatment that is both more effective and gentle for people with a rectal cancer diagnosis. The APHRODITE trial is one of the first studies to show that increasing the radiotherapy dose using standard NHS equipment can significantly improve how rectal cancer responds to treatment. If longer-term findings confirm these results, this approach could help expand treatment options, offering more people the chance to avoid major surgery while maintaining their quality of life.”

Dr Stuart Griffiths, Director of Research, Policy and Impact at Yorkshire Cancer Research said: “The APHRODITE trial is a clear example of how Yorkshire Cancer Research is helping to make Yorkshire a research-active region. By working with pioneering cancer experts, the charity is bringing innovative clinical trials to people in our region, so they can be among the first to benefit from the latest breakthroughs in cancer treatment.

“Research shows people treated at hospitals where high levels of research take place often do better than those treated in hospitals with little or no clinical research. That is why we are committed to working alongside hospitals and universities across the region to make Yorkshire a thriving hub for cancer research. As Christine’s experience demonstrates, access to innovative treatments through clinical trials can help people live longer, healthier, cancer-free lives.”

Find out more about life-saving cancer research in Yorkshire: Saving lives through research - Yorkshire Cancer Research

Ends

Contact: Maddie Grounds, PR Manager, Yorkshire Cancer Research. Tel: 01423877228

Email: maddie.grounds@ycr.org.uk

About the APHRODITE trial

• APHRODITE involved 119 people with early or intermediate-stage rectal cancer at 11 UK hospitals.

• It tested whether giving a higher radiotherapy dose to the tumour (62Gy instead of 50.4Gy) could increase the chance of complete tumour response 6 months after start of treatment

• Six months after start of treatment, no cancer could be detected in 49% of patients receiving the higher dose, compared with 33% receiving the standard dose.

• This represents around 16 additional complete responses for every 100 patients treated.

• Serious short-term side effects were very uncommon, although mild bowel and rectal side effects were slightly more frequent with the higher dose.

• Patient-reported symptoms and quality of life were similar between the two treatment groups.

• APHRODITE was delivered by the Leeds Clinical Trials Research Unit [https://ctru.leeds.ac.uk], which specialises in cancer and radiotherapy trials and has worked with Yorkshire Cancer Research to bring many pioneering clinical trials to people in Yorkshire and beyond.

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