RecruitingNAINTERVENTIONAL

Non-operative Management for Locally Advanced Rectal Cancer

This study is for people with a type of bowel cancer called 'low rectal cancer' who have had chemotherapy and radiotherapy. Traditionally, these patients would then have surgery, which often means having a permanent colostomy and can have a big impact on daily life. This research wants to see if we can safely avoid surgery for some patients who respond exceptionally well to their initial treatments. Instead, these patients would be very carefully monitored. The study will track how many patients might need surgery later if the cancer shows signs of returning, and whether the cancer can be completely removed if surgery does become necessary. It's a five-year study hoping to show that avoiding immediate surgery for these specific patients is a safe and effective option.

At a glance

Status

Recruiting

Phase

Sponsor

Mount Sinai Hospital, Canada

Enrolment target

Start

16 Mar 2018

Estimated completion

01 Dec 2026

Rectal Neoplasms

What is this study about?

This research is looking into a different way to manage certain bowel cancers that are quite low down in the body, known as 'low rectal cancer'. For many years, the standard treatment has involved a combination of chemotherapy and radiotherapy, followed by an operation to remove the cancer. This surgery often means that patients will need a permanent colostomy, which is where a part of the bowel is brought out to a bag on the tummy. This can have a big impact on a person's life, including how their body looks, and their bowel and sexual function.

Because of these significant effects, doctors are very interested in finding ways to avoid surgery for some patients, if it's safe to do so. This study focuses on patients who have an excellent response to their initial chemotherapy and radiotherapy – so good, in fact, that doctors can no longer see any signs of the cancer. For these specific patients, instead of going straight to surgery, the study proposes to carefully watch them over time to see if the cancer stays away. This watchful waiting approach is called 'non-operative management'.

The main goal of this study is to check if this watchful waiting approach is safe. They want to find out how often the cancer might come back in the local area, and if it does, whether it can still be successfully removed by surgery. If the results show that watchful waiting is safe and works just as well as immediate surgery for controlling the cancer in these carefully selected patients, it could change how this type of cancer is treated in the future, potentially helping many people avoid major surgery and its long-term effects.

Key takeaways

This study explores avoiding surgery for specific rectal cancer patients.
It's for those with no visible cancer after initial treatments.
Participants will be closely watched with regular tests and scans.
The aim is to improve quality of life by potentially avoiding a permanent colostomy.
Safety is the main focus, monitoring local cancer return.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. You must have completed your chemotherapy and radiotherapy treatment for low rectal cancer as part of your usual care. The doctors need to have planned or considered surgery that would likely lead to a permanent colostomy for you.

Crucially, after your initial treatments, your doctors must confirm that all signs of the cancer have completely disappeared. This means they can't feel any cancer on examination, there's no visible cancer on scans or during a camera test, and your blood tests for a specific marker (CEA) are normal. You also need to be able to have an MRI scan.

You wouldn't be able to join if your cancer has already spread to other parts of your body, or if you have another ongoing cancer or certain other health conditions like inflammatory bowel disease. You also can't be pregnant, or considered too unwell for surgery.

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.

Have I had chemotherapy and radiotherapy for low rectal cancer?
Has my doctor told me that all signs of my cancer have disappeared after treatment?
Am I 18 years old or older?
Am I able to have an MRI scan?
Has my cancer not spread to other parts of my body?

Answer every question to see your result.

What does participation involve?

If you decide to take part, and meet all the study requirements, you wouldn't have immediate surgery after your chemotherapy and radiotherapy. Instead, you would be closely monitored over a period of five years. This involves regular check-ups and tests to ensure the cancer hasn't returned.

These check-ups would include: a physical examination, a camera test of your bowel (endoscopy), and MRI scans of your pelvis. Initially, these would happen every 3 months for the first year, then every 6 months for the second year. You would also have blood tests (CEA levels) every 3 months for the first two years, then every 6 months for the next few years. In addition, you'd have CT scans of your chest and tummy at specific intervals. The exact schedule will be explained fully by the study team. You would attend appointments at the hospitals taking part in the study.

Potential risks and benefits

Taking part in this study means you might avoid major surgery and its associated challenges, which could significantly improve your quality of life. However, there's a risk that the cancer could regrow locally, and then you would need surgery – potentially a more complex operation. The study is carefully designed to monitor you very closely to detect any regrowth early. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Sinai Health System
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'non-operative management'?

It means closely watching your cancer after treatment, without having immediate surgery, to see if it truly went away.

Who is this study for?

It's for people with low rectal cancer who've had chemotherapy and radiotherapy and no longer show any signs of cancer.

Will I still need check-ups if I join?

Yes, you'll have very regular check-ups, scans, and blood tests to make sure the cancer hasn't come back.

What if the cancer grows back during the study?

If the cancer shows signs of returning, you would then have surgery to remove it, similar to the standard treatment.

How long does the study last?

The study will follow participants for five years to understand the long-term safety of this approach.

How to find out more

Erin Kennedy

erin.kennedy@sinaihealthsystem.ca 416-586-4800 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.