Rectal cancer patients could be spared surgery
Four in five patients with early and intermediate-stage rectal cancer could be spared life-changing surgery by giving them a combination of chemotherapy and radiotherapy, a UCL-led trial has found.
The STAR-TREC trial (Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early Rectal Cancer) found that chemoradiotherapy, with rectum-preserving surgery only when needed, allowed four in five such patients to keep their rectum. Their findings, from Phases Two and Three of the trial, are published in The Lancet Oncology.
The standard treatment for rectal cancer is extensive surgery to remove the whole rectum, which often leaves patients with lasting side effects such as bowel dysfunction, sexual and urinary problems, and a permanent colostomy bag.
The introduction of bowel screening programmes means more people are now being diagnosed earlier – and the earlier the cancer is found, the less invasive the treatment can be and the more likely a patient is to survive.
This prompted the UCL researchers to ask whether early and intermediate-stage rectal cancer patients could be treated without surgery. Their trial is the first partially randomised controlled trial to compare standard surgery with organ-preserving approaches for early and intermediate -stage rectal cancer.*
The researchers hope that chemoradiotherapy, with rectum-preserving surgery only when needed, will become a standard treatment option on the NHS in England in the near future.
Simon Bach, co-chief investigator of the STAR-TREC trial 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, that 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.”
For the trial – by far the largest of its kind – more than 500 patients were recruited across England, the Netherlands, Denmark, Belgium and Sweden.
They were split into three groups. The first received the current standard treatment of radical surgery. The other two tested new treatments aimed at organ preservation: one had five weeks of chemoradiotherapy; the other had five days of radiotherapy. Patients given radiotherapy or chemoradiotherapy only went on to have radical surgery only if this treatment alone did not shrink 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.
In the group of 163 patients who had five weeks of chemoradiotherapy, by 12 months 93 (57.1 per cent) were cancer-free without further treatment; 35 (21.5 per cent) had less invasive surgery where a small area of cancer persisted; and 35 (21.5 per cent) needed radical surgery.
In the group of 168 patients who had five days of radiotherapy, by 12 months; 53 (31.5 per cent) were cancer-free without further treatment; 49 (29.2 per cent) had rectum-preserving surgery; and 66 (39.3 per cent) needed radical surgery.
At 12 months, five weeks of chemoradiotherapy was 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 up to three years, to monitor whether the cancer is more likely to return without radical surgery, and whether there is a difference in survival. They expect to publish updated findings at the 30-month stage in mid-2027.
Cancer Research UK and Stand Up to Cancer are funding the trial. 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.”
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.”
Patient’s story
Hugh Chown, 65, from Harrogate, joined the STAR-TREC trial at Leeds Teaching Hospitals NHS Trust in January 2021 after being diagnosed with rectal cancer in December.
His wife, Janet, died aged 41 after being diagnosed with bowel cancer in 2001.
Hugh received chemoradiotherapy and has avoided the need for surgery. Three months after treatment his cancer had disappeared and he remains cancer-free.
He said: “The diagnosis 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 told me about a clinical trial called STAR‑TREC. She explained that the usual treatment would be surgery and it was highly likely I’d be left with a permanent colostomy bag. The decision wasn’t difficult.
“My treatments consisted of taking two batches of tablets and receiving one radiotherapy session a day, five days per week for five weeks.
“Although I felt fatigued during the treatment, it was minimal compared to the potential alternative.”
Around 4,100 people in England are diagnosed with early-stage rectal cancer each year, which is a type of bowel cancer.
* The whole trial was not randomised – only the second phase was. For the third phase, participants were allowed to choose to have the standard surgery if they wanted to.
Source: University College London.
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