Active not recruitingNAINTERVENTIONAL

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

This study is investigating a new way to treat difficult rectal cancers. Rectal cancer can sometimes grow into nearby areas or come back after initial treatment, making it harder to remove completely. After surgery to take out as much cancer as possible, some tiny cells might remain. This trial tests a treatment called Intraoperative Electron Radiotherapy (IOERT), which delivers radiation directly to the area during surgery to destroy these remaining cells. Patients will be randomly assigned to receive standard surgery, or surgery plus one of two different doses of IOERT. The goal is to see if IOERT can help ensure all cancer cells are removed, improving the chances of a successful recovery.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

18 May 2022

Estimated completion

25 Apr 2027

Locally Advanced Rectal Cancer Locally Recurrent Rectal Cancer

What is this study about?

This study focuses on a type of cancer that starts in the rectum, which is the last part of your large bowel. When this cancer grows outside the rectum into nearby areas, or if it comes back after previous treatment, it can be quite challenging to treat effectively. Usually, the treatment involves chemotherapy and radiotherapy, followed by a big operation to remove all affected parts and make sure no cancer cells are left behind. If even tiny cancer cells remain at the edge of where the surgery was done, there's a higher chance the cancer could return.

That's where this new approach, called Intraoperative Electron Radiotherapy (IOERT), comes in. The idea is to target any potential cancer cells that might be left behind during the same surgery. After the surgeon has removed the main tumour, they, along with a specialist who plans radiation treatment, will carefully check the area. If they think there's a risk that some very tiny cancer cells might still be there, they can use IOERT. This treatment delivers a focused beam of radiation directly to that area during the operation, aiming to destroy those microscopic cells on the spot.

This study wants to find out if adding IOERT to the standard surgery makes a difference. Patients taking part will be randomly put into one of three groups: one group will have the standard surgery only, another group will have the surgery plus a standard dose of IOERT, and the third group will have the surgery plus a slightly higher dose of IOERT. The medical team and the patient won't know which treatment group the patient is in, to ensure the study is fair. The aim is to see if IOERT, especially at different doses, can improve patient recovery by ensuring as many cancer cells as possible are removed.

Key takeaways

This study evaluates IOERT during rectal cancer surgery.
It targets advanced or returning rectal cancer.
Compares standard surgery with two doses of IOERT.
Aims to destroy remaining cancer cells for better outcomes.
Participation involves random assignment to a treatment group.
Follow-up is for at least 12 months for the study, and 5 years for general care.

Who may be eligible?

To be considered for this study, you need to be at least 16 years old. You must have rectal cancer that has either spread locally (meaning it’s grown outside the rectum but hasn't spread widely to other parts of your body) or has come back after previous treatment. Importantly, the cancer must be in a place in the pelvis where doctors believe it can be removed with surgery, even if it’s very close to other important structures.

The decision about whether this study is right for you will involve a team of cancer specialists. They need to agree that IOERT is a suitable part of your treatment plan, and you must be generally fit enough for the surgery, meaning you can move around and look after yourself well. All patients will need to give their written permission to take part.

You cannot join if the doctors think your cancer cannot be fully removed by surgery, or if you've already had a lot of radiation treatment in the specific area that would receive IOERT. Also, pregnant or breastfeeding women cannot participate. If you've taken part in another clinical trial recently, that might also prevent you from joining.

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.

Are you 16 years old or older?
Do you have rectal cancer that has spread locally or come back, but can still be removed by surgery?
Are you generally fit enough for surgery?
Are you NOT pregnant or breastfeeding?
Have you discussed this with your cancer care team, and are they considering IOERT as an option for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is giving your written consent. On the day of your surgery, you will be randomly assigned to one of three groups: either standard surgery only, surgery plus a standard dose of IOERT, or surgery plus a slightly higher dose of IOERT. Neither you nor your medical team will know which group you are in, which helps make the study fair. After your surgery, the research team will keep in touch with you. You'll have check-ups at 30 days and 3 months after your operation, and then for at least 12 months as part of the study. Beyond that, your health will continue to be monitored for up to 5 years as part of your regular cancer care.

Potential risks and benefits

Taking part in this study may offer benefits, such as potentially receiving an advanced treatment (IOERT) that aims to destroy any remaining cancer cells during surgery, which might improve your chances of a successful long-term outcome. However, as with any surgery and radiation, there are potential risks, including side effects from the treatment itself. The medical team will discuss all known risks and benefits with you in detail. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom

Common questions

What is 'Locally Advanced' or 'Locally Recurrent' Rectal Cancer?

It means the cancer in your rectum has either grown into nearby organs or tissues in your pelvis, or it has returned in the same area after you had previous treatment.

What is IOERT?

IOERT stands for Intraoperative Electron Radiotherapy. It's a special type of radiation treatment given directly to the area where the cancer was during your surgery, to kill any tiny cancer cells that might be left behind.

Will I know if I'm getting IOERT?

No, because this is a 'blinded' study, neither you nor the doctors performing the surgery will know which treatment group you are in. This helps to ensure the results are unbiased.

How long will I be followed up after my surgery?

You will have specific study follow-ups for at least 12 months, and then your health will continue to be monitored for up to 5 years as part of your standard cancer care.

Can I leave the study if I change my mind?

Yes, completely. You have the right to withdraw from the study at any time without having to give a reason, and this will not affect your ongoing medical care.