A feasibility study of electron radiotherapy delivered during a surgical operation for rectal cancer
Rectal cancer that has grown into nearby tissues or returned after earlier treatment can be difficult to remove completely. Standard care involves chemotherapy and radiotherapy, followed by an operation to clear the cancer. However, tiny cancer cells can sometimes remain at the edges of the surgical area, raising the risk of the cancer returning. In this study, doctors are testing intraoperative electron beam radiotherapy (IOERT). This gives a precise dose of radiation to the pelvic area while the patient is still asleep in the operating theatre, right after the tumour is taken out. Researchers want to find out if this extra treatment is safe and practical. Patients will be randomly placed into one of three groups: standard surgery alone, or surgery with one of two different doses of radiation. This study will help doctors learn if IOERT improves long-term outcomes for future bowel cancer patients.
At a glance
What is this study about?
Rectal cancer starts in the rectum, which is the lower part of the bowel. When the cancer is advanced or returns after earlier treatment, it often sticks to other pelvic organs or tissues. The standard approach involves chemotherapy and radiotherapy to shrink the cancer, followed by major surgery to remove the tumour along with a healthy border of tissue around it.
Even with careful surgery, a few cancer cells can sometimes be left behind at the edges of the tissue. If this happens, the cancer has a higher chance of coming back. To prevent this, doctors have developed a technique called intraoperative electron beam radiotherapy, or IOERT. This method delivers a quick, highly targeted dose of radiation directly to the pelvic area during surgery, immediately after the surgeon removes the tumour.
This study aims to find out if adding IOERT during surgery is safe and feasible within the NHS. By comparing standard surgery to surgery combined with one of two doses of radiation, researchers hope to see if this treatment helps clear remaining cancer cells and gives patients the best possible chance of long-term recovery.
Key takeaways
- Tests giving a targeted dose of radiotherapy directly during pelvic surgery.
- Aims to destroy any microscopic cancer cells left behind to stop cancer returning.
- Involves patients aged 16 and over with advanced or returning rectal cancer.
- Participants are placed into one of three study groups by chance.
- Trial follow-ups run for 12 months, followed by standard 5-year NHS monitoring.
Who may be eligible?
You may be able to take part if you are 16 or older and have rectal cancer that is locally advanced or has come back in the pelvis. A specialist cancer care team must agree that an operation is suitable for you and that you are generally fit enough to safely undergo major surgery. If the cancer has spread to other parts of the body, you may still join if there are only up to three small spots that can also be treated.
You cannot join if the surgeon believes the tumour cannot be completely removed, or if you have already had too much radiotherapy to that specific pelvic area in the past. Women who are pregnant or breastfeeding are unable to take part, as are people who have taken part in another clinical trial within the past three months.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 16 or over.
- I have been diagnosed with advanced or recurrent rectal cancer.
- My medical team has planned major surgery to remove my tumour.
- I am medically fit enough to have an operation.
- I am not pregnant or breastfeeding.
What does participation involve?
If you take part, you will have your planned operation at University Hospital Southampton. On the day of your surgery, a computer will place you by chance into one of three groups: standard surgery without IOERT, surgery with a lower radiation dose, or surgery with a higher radiation dose. Neither you nor your surgical team will know which group you are in, ensuring the test is fair. The extra radiotherapy is delivered while you are under general anaesthetic, so it does not require an extra trip to the operating room. After your surgery, you will have follow-up visits at 30 days, 3 months, and 12 months to check your recovery. Your hospital team will then continue to check on your health for 5 years as part of your normal NHS care.
Potential risks and benefits
Locations (1)
- Southampton General HospitalUnverifiedSouthampton, England
Common questions
Will I be awake during the radiotherapy?
No. The radiation is given while you are under general anaesthetic during your operation, so you will not feel or see anything.
Can I choose which dose of radiotherapy I receive?
No. A computer randomly decides whether you receive standard surgery alone or surgery with one of two radiotherapy doses. This keeps the study fair and unbiased.
Will joining the study delay my cancer surgery?
No. The study takes place as part of your scheduled surgery, so it will not hold up your treatment timeline.
What happens if I decide to leave the trial?
You are free to leave the study at any stage. Your doctors will continue to give you the standard NHS care and support you need.
Will I need to travel for lots of extra appointments?
Most trial checks happen at 30 days, 3 months, and 12 months after your operation, and these are usually timed alongside your routine post-surgery visits.
How to find out more
Daniel Griffiths
Always speak to your GP or specialist before deciding to take part in a study.
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