A major new clinical trial has raised the possibility that many people with early-stage rectal cancer could avoid radical surgery and keep their rectum following chemoradiotherapy.
The findings from the international STAR-TREC trial have been described as potentially life-changing for people diagnosed with rectal cancer.
Researchers found that around four in five patients who received a five-week course of chemoradiotherapy were able to avoid radical rectal surgery one year later.
For some patients, this could mean avoiding a permanent stoma, as well as some of the bowel, urinary and sexual problems that can follow major rectal surgery.
The results are particularly significant because treatment for rectal cancer has traditionally involved surgery to remove the affected part of the rectum. Although surgery can be highly effective in treating cancer, it can also have substantial and permanent consequences for quality of life.
The research does not mean that surgery is no longer required for rectal cancer. Rather, it suggests that organ-preserving treatment may be a realistic option for carefully selected patients.
What did the STAR-TREC trial find?
The STAR-TREC trial was an international phase II/III clinical trial involving patients with early or intermediate-stage rectal cancer.
The research compared different approaches to treating the cancer, including:
- radical surgery;
- a five-week course of chemoradiotherapy; and
- a short five-day course of radiotherapy.
Patients receiving the organ-preserving approaches were assessed following treatment. Where the tumour responded sufficiently, radical surgery could be avoided. Where a small amount of cancer remained, a more localised procedure could sometimes be used instead.
The published results found that 79.8% of patients treated with chemoradiotherapy were free from total mesorectal excision at 12 months. The corresponding figure for those receiving short-course radiotherapy was approximately 61%.
The trial therefore provides important evidence that treatment aimed at preserving the rectum can work for a substantial proportion of appropriately selected patients.
The original research paper is available through the academic record for the study and was published in The Lancet Oncology.
Why is avoiding rectal surgery potentially so important?
Surgery for rectal cancer can save lives. However, removing the rectum is a major operation and can have consequences that continue long after the cancer itself has been treated.
Depending upon the location of the tumour and the operation required, patients can experience changes to bowel function, urinary problems and sexual dysfunction.
Some patients also require a stoma, sometimes permanently.
A stoma is an opening made through the abdominal wall so that waste can leave the body into a bag attached outside the body. For some people, a permanent stoma is an essential and successful part of their cancer treatment. For others, avoiding the need for one may represent a very significant improvement in their quality of life.
The researchers behind STAR-TREC have therefore been investigating whether the rectum can be preserved without compromising effective cancer treatment.
The trial’s original protocol specifically recognised that organ-preserving treatment could potentially reduce treatment-related side effects and preserve quality of life compared with total mesorectal excision.
What is chemoradiotherapy?
Chemoradiotherapy combines chemotherapy and radiotherapy.
Radiotherapy uses high-energy radiation to destroy cancer cells. Chemotherapy uses anti-cancer medicines that circulate through the bloodstream and can destroy cancer cells or prevent them from growing.
When the two treatments are given together, the chemotherapy can also make cancer cells more sensitive to radiotherapy.
For rectal cancer, chemoradiotherapy may be given before surgery. Treatment before surgery is known as neoadjuvant treatment.
Cancer Research UK explains that chemoradiotherapy is one of the established treatments used for rectal cancer and that treatment decisions depend upon factors including the stage and position of the cancer.
Does this mean rectal cancer patients no longer need surgery?
No.
This is an important point.
The STAR-TREC results are extremely encouraging, but they do not mean that surgery has become unnecessary for everyone with rectal cancer.
The trial looked at selected patients with early or intermediate-stage disease and examined whether treatment could preserve the rectum.
The longer-term results remain important.
Cancer can sometimes return locally after an apparently successful response to treatment. Consequently, patients managed without immediate radical surgery need careful and continuing surveillance.
The current NICE guidance recognises the possibility of a watch-and-wait approach for some patients who have had a complete clinical and radiological response to treatment. However, NICE also stresses the uncertainty surrounding this approach and notes that some patients may subsequently experience local regrowth requiring salvage surgery.
The significance of STAR-TREC is therefore not that surgery has been abandoned. It is that doctors may increasingly be able to identify patients for whom preserving the rectum is a realistic treatment objective.
What happens if the tumour does not completely disappear?
One of the important features of the STAR-TREC approach is that patients were not simply left without treatment if their cancer did not respond sufficiently.
Treatment was adapted according to the response.
Where small areas of cancer remained, patients could undergo a more localised procedure rather than automatically proceeding to radical surgery.
This is an important development because modern cancer treatment is increasingly moving towards response-adapted and personalised treatment.
Instead of every patient receiving exactly the same treatment, doctors can assess how an individual cancer has responded and then decide what should happen next.
Could this change bowel cancer treatment in the future?
Potentially.
The STAR-TREC findings add to a growing body of research examining whether some rectal cancer patients can be treated successfully without immediate radical surgery.
Cancer Research UK describes STAR-TREC as a trial involving people with early-stage rectal cancer and confirms that the trial has now closed to recruitment.
There is also continuing research into how doctors can identify which patients are most likely to respond to organ-preserving treatment.
This is important because the ultimate aim is not simply to avoid surgery. It is to avoid unnecessary major surgery without compromising the chances of controlling or curing the cancer.
Cancer Research UK and the Royal College of Surgeons of England have also been working on initiatives designed to improve the use of neoadjuvant treatment and help identify patients who may benefit from avoiding surgery.
Why early diagnosis of bowel cancer remains so important
The potential treatment breakthrough also highlights another important issue: the earlier bowel cancer is diagnosed, the greater the range of treatment options may be available.
Screening has increased the number of bowel cancers detected at an earlier stage. Early-stage rectal cancer can be particularly suitable for research into organ-preserving treatments because the disease has not yet progressed as far.
This is one reason why delays in diagnosing bowel cancer can be so serious.
If bowel cancer is diagnosed later than it should have been, the cancer may have had more time to grow or spread. That can potentially affect the treatment required and the patient’s prognosis.
For more information about the legal issues that can arise where cancer has not been diagnosed promptly, see our guide to delayed cancer diagnosis and compensation.
We also have specific information about delayed bowel cancer diagnosis, including circumstances in which a failure to investigate symptoms or act upon test results may potentially result in a claim.
What symptoms of bowel cancer should not be ignored?
Bowel cancer can cause a variety of symptoms, although having one of these symptoms does not necessarily mean that a person has cancer.
Symptoms can include:
- blood in the stool or bleeding from the back passage;
- a persistent change in bowel habits;
- unexplained weight loss;
- persistent abdominal discomfort or pain;
- unexplained tiredness;
- a feeling that the bowel has not completely emptied; and
- a lump or swelling in the abdomen.
Some people may have bowel cancer without experiencing obvious symptoms, which is why bowel cancer screening is important.
Anyone concerned about symptoms should seek medical advice rather than waiting to see whether they disappear.
Could a delay in diagnosing rectal cancer make a difference?
In some cases, yes.
Cancer treatment is highly dependent upon the stage and characteristics of the disease at the time it is diagnosed.
A delay does not automatically mean that medical negligence has occurred. Doctors must be assessed according to the circumstances and information available to them at the relevant time.
However, where symptoms or warning signs should reasonably have led to further investigation, but there was an avoidable delay in referral, investigation or diagnosis, the consequences can sometimes be serious.
A delayed diagnosis can potentially mean that a cancer is discovered at a more advanced stage, when treatment may be more extensive.
This is particularly important in light of developments such as STAR-TREC. The more doctors understand about treating cancer at an early stage, the more important it becomes that patients are given the opportunity to receive appropriate investigations and treatment promptly.
What does the STAR-TREC research mean for patients?
The most important message is one of hope, but also caution.
For selected patients with early or intermediate-stage rectal cancer, chemoradiotherapy may provide an opportunity to preserve the rectum and avoid radical surgery.
The trial found that approximately four out of five patients receiving the five-week chemoradiotherapy approach avoided total mesorectal excision at 12 months.
That is a striking result.
However, the researchers themselves have stressed the need for longer-term follow-up before the results can be fully translated into routine treatment for every suitable patient.
Treatment decisions must continue to be made by specialist cancer teams after considering the individual patient’s cancer, scans, stage, general health and preferences.
The research does, nevertheless, represent an important step towards less invasive and more personalised treatment for rectal cancer.
The importance of timely bowel cancer diagnosis
Bowel cancer treatment is continuing to develop rapidly.
The STAR-TREC results demonstrate how treatments that might once have seemed experimental can potentially change the way cancer is managed. For some patients, the future may involve treating the cancer effectively while preserving as much normal anatomy and function as possible.
But this depends upon the cancer being identified and assessed at the appropriate stage.
If you or someone close to you has experienced a delay in the diagnosis of bowel or rectal cancer and you believe that earlier investigation or treatment should have taken place, it may be appropriate to obtain specialist legal advice.
At R James Hutcheon Solicitors, we investigate claims involving delayed cancer diagnosis and medical negligence, including cases where a delay may have affected the treatment required or the patient’s prospects of recovery.
The law surrounding clinical negligence is complex, and a poor outcome does not by itself establish negligence. Each case needs to be considered on its own facts and medical evidence.
Contact Us Now To Claim
Original and authoritative sources
- STAR-TREC research – The Lancet Oncology: Chemoradiotherapy versus short-course radiotherapy for response-adapted organ preservation in early and intermediate-stage rectal cancer
- Cancer Research UK: STAR-TREC clinical trial information
- NICE: Colorectal cancer – diagnosis and management (NG151)
- Cancer Research UK: Treatment for bowel (rectal) cancer
