Cancer patients have avoided the need for major surgery and a permanent colostomy bag after taking part in a major international trial co-led by the Universities of Leeds and Birmingham.
The patients, who all had early-stage rectal cancer, were treated with combinations of chemotherapy and radiotherapy to see if they could safely avoid major surgery, which is the current standard of care.
Published today in Lancet Oncology and funded by Cancer Research UK, the initial results suggest that organpreserving treatment may be a realistic option for many people with early rectal cancer – and has fewer side effects than major surgery.
The trial, named STAR-TREC, was co-led by Professor David Sebag-Montefiore in Leeds and Professor Simon Bach at UCL, and co-ordinated by the University of Birmingham. Patients were recruited to trial centres in the UK, the Netherlands, Sweden, Denmark and Belgium.
These exciting results are an example of how a smarter, kinder radiotherapy treatment may allow patients to avoid the need for major surgery.
Kinder treatment
Professor Sebag-Montefiore 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."
Professor Bach 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. What these results suggest is 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."
Standard care
Up to 14,000 people are diagnosed with rectal cancer in the UK every year. Of these, around one in three are at an early stage.
Patients are usually treated with a complex surgical procedure called a Total Mesorectal Excision (TME), which involves the complete removal of the rectum, the surrounding fat, and lymph nodes.
The surgery has a high cure rate – but can have a significant impact on patients' bowel, bladder, and sexual function, and may also require a temporary or permanent colostomy bag, significantly affecting their quality of life.
Trial results
The team set out to discover whether organ-preserving treatments - radiotherapy and chemotherapy - could help patients avoid surgery while keeping the cancer under control.
The 426 patients were initially randomised to one of three groups: receiving either long-course chemoradiotherapy, short-course radiotherapy, or standard surgery.
Longcourse chemoradiotherapy is radiotherapy delivered over five weeks plus chemotherapy tablets, while shortcourse radiotherapy is delivered over one week. They are known as organ-preserving treatments.
Patients whose cancer was not completely eradicated by their treatment had a surgical procedure to remove the remaining areas affected by cancer.
The results show that for up to 12 months, four out of five patients treated with chemotherapy and radiotherapy avoided major surgery, compared with three out of five treated with radiotherapy alone.
Patients' progress was followed for 30 months. These results are still being analysed, and the longer-term results are expected to be published later next year.
Patient benefits
Michelle Mitchell, Cancer Research UK's chief executive, said: "This breakthrough could be life-changing for thousands of people.
"Thanks to bowel screening, more rectal cancers are being spotted at an earlier stage, where people are more likely to survive the disease, but that hasn't made treatment any easier - many patients still have to cope with extremely difficult and often life-altering side effects.
"Remarkably, that could finally be about to change with this new treatment option, which has the potential to transform the lives of people affected by this cancer and their families."
Hugh's story
Hugh Chown, 65, from Harrogate, was diagnosed with rectal cancer on 30 December 2020 at Leeds Cancer Centre. He joined the STAR-TREC trial in January 2021. He was supported by his daughter Rachel Chown, 33, who is Associate Director of Research and Innovation at The Christie NHS Foundation Trust in Manchester, a specialist cancer treatment centre. Rachel's mum and Hugh's wife, Janet, died aged 41 after being diagnosed with bowel cancer in 2001. Janet received surgery, chemotherapy and radiotherapy, but sadly died after 14 months.
Hugh is now married to Sandra. He is also dad to Rachel's sister Isobel, stepdad to Rosie and Eve, and step-grandad to Ava, four.
Hugh received chemoradiotherapy at Leeds Teaching Hospitals NHS Trust and has avoided the need for surgery and a colostomy bag. Three months after treatment, his cancer had disappeared, and he remains cancer-free.
Treatment choice
He said: "I'd had two to three months of occasional bleeding, so I contacted my GP and was sent for a colonoscopy. On 30th December, I got the diagnosis – it was totally unexpected. I was shocked but accepting of it. I knew worrying wouldn't help, so I just focused on living life.
"Two weeks later, my consultant at Harrogate told me about a clinical trial called STARTREC. She explained that the usual treatment would be surgery and it was highly likely I'd be left with a permanent colostomy bag.
"Then she said there was a trial I might be eligible for. She thought I had a good chance of a positive outcome and explained how the trial worked. The decision wasn't difficult. She later confirmed I was a suitable candidate. The worstcase scenario was that the treatment wouldn't work and I'd need surgery anyway, which would be delayed by about three and a half months because of the trial. But the cancer was at a very early stage."
Recovery
"Before my treatment started, I was advised to get as fit as possible so I did two hours a day of cycle training in the weeks leading up to it.
"My treatments consisted of taking tablets morning and evening and receiving one radiotherapy session a day, 5 days per week for 5 weeks. For the first two weeks, the side effects were minimal but by the middle of the third week, I started to feel run down and tired and this got worse as the treatment went on.
"The fatigue also continued to get worse for a few weeks after the treatment stopped. I was fortunate that at no point did I feel nauseous. The effects took about 6 months to wear off completely, but I was more or less back to normal after 2 months.
"Although I felt fatigued during the treatment, it was minimal compared to the potential alternative, which is major surgery and permanent colostomy bag - a life- changing procedure.
"As my side effects were not severe, I was able to drive myself to and from the hospital in Leeds for all of the treatment.
"At the end of 12 weeks, I had another colonoscopy. The consultant said I'd had a perfect result and the cancer was gone, but because it was part of the trial, I had another one at 16 weeks and all was still clear. After that, the treatment ended and I moved on to regular checks for the trial which lasted a total of three years, then standard NHS cancer checks for a further two years. My last check was in May this year and everything was fine."
Family perspective
Hugh's daughter Rachel said: "We're both quite pragmatic, but my work also gave me perspective, and I had colleagues I could talk to. I was nine when my mum died of bowel cancer, but outcomes now are very different. Patient survival is improving all the time, and in many cases, people are now living well with and beyond cancer.
"I felt fortunate because my work in cancer care and research helped me understand the choices Dad was offered, and what they meant. When I heard about the trial, I felt strongly that it was his best option. From my experience, I know how diligently trials are conducted and how much followup they involve, so I was confident he'd get excellent care at Leeds."
