Clinical trial finds new rectal cancer treatment spares major surgery and side effects

A new treatment for earlier-stage rectal cancer could transform how patients are treated for the disease, according to a landmark clinical trial.

The clinical trial was coordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham, with academics from UCL and the University of Leeds. The trial found that chemoradiotherapy, with rectum-preserving surgery only when needed, allowed four in five patients to keep their rectum, sparing them major side effects.

The findings, published in The Lancet Oncology, have led researchers to hope that this will become a standard treatment option in the future.

Prof Simon Bach, co-chief investigator of the STAR-TREC trial, Honorary Chair at the University of Birmingham and Professor of Colorectal Surgery at University College London, said: “For decades we’ve asked patients to accept the loss of their rectum – and often a permanent stoma – as the price of curing their cancer. These results suggest that for many people, this price no longer has to be paid.

“Four in five patients treated with chemoradiotherapy kept their rectum. The next step is to confirm these results hold over the longer term, and then to make sure the approach is available to every patient who could benefit.”

Around 4,100 people in England are diagnosed with early-stage rectal cancer each year, which is a type of bowel cancer. Patients are currently treated for the disease with radical surgery that removes the whole rectum, often leaving them with life-changing side effects such as bowel dysfunction, sexual and urinary problems, and a permanent colostomy bag.

Clinical trial across five European countries

More than 500 patients were recruited from the United Kingdom, Netherlands, Denmark, Belgium and Sweden. They were split into three groups, two of which tested new treatments aimed at organ preservation:

1. The current standard treatment of radical surgery
2. Five weeks of chemoradiotherapy
3. Five days of radiotherapy

Patients who were given radiotherapy or chemoradiotherapy only had radical surgery if this treatment alone was not shrinking their tumour enough. Where small areas of cancer persisted, these were removed by rectum-preserving surgery – a smaller, local operation that is less invasive and reduces the chance of side effects.

After 12 months, five weeks of chemoradiotherapy was shown to be the more effective of the two organ-preserving approaches: patients in this group were less likely to require radical surgery than those who had five days of radiotherapy.

Researchers are now following patients for the next three years, to monitor whether the cancer is more likely to come back without radical surgery, and whether there is a difference in survival.

David Sebag-Montefiore, co-chief investigator of the STAR-TREC trial and Professor of Clinical Oncology at the University of Leeds, said: “These exciting results are an example of how a smarter, kinder radiotherapy treatment may allow patients to avoid the need for major surgery. It is gratifying that patients experienced a relatively low level of severe short-term side effects as a result of the smaller, more targeted radiotherapy approach that we specifically developed for STAR-TREC."

Birmingham is a leading global hub in clinical trial design and innovation; its credibility rests on an ecosystem of skills, data and infrastructure which has proven especially valuable in paediatric cancer research.

The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham is one of Cancer Research UK’s network of funded clinical trials units. The CRCTU designs and delivers trials across all phases and collaborating nationally and internationally, with an emphasis on innovative design approaches suitable for small patient groups. 

STAR-TREC Phase II/III trial was funded by Cancer Research UK and Stand Up to Cancer.