RecruitingNAINTERVENTIONAL

Patients With Rectal Cancer: a "Wait-and-see" Approach

This study explores a different way to treat rectal cancer. Patients first receive radiotherapy and chemotherapy. After this, instead of automatically having surgery, doctors carefully monitor the cancer's response using scans and other tests. If the treatment makes the cancer disappear completely, the study investigates whether a 'wait-and-see' approach is safe and effective. This means delaying or avoiding surgery, which can have significant side effects like long-term bowel problems or the need for a permanent stoma. The goal is to see if patients can get good long-term results without immediate surgery, improving their quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

Start

01 Mar 2015

Estimated completion

01 Jan 2026

Colorectal Carcinoma

What is this study about?

This study is for people who have been diagnosed with a type of bowel cancer called rectal cancer. Usually, after radiotherapy and chemotherapy for rectal cancer, surgery is performed to remove the tumour. This surgery is often very effective at getting rid of the cancer, but it can also cause significant side effects that affect a person's daily life, such as issues with bowel control, problems with bladder function, and sexual health concerns. For some people, particularly those whose cancer is very low down in the bowel, surgery might even mean needing a permanent stoma, which is an opening in the tummy to collect waste.

Doctors have noticed that for some patients, the radiotherapy and chemotherapy treatment can be so effective that the cancer completely disappears. If this happens, is it always necessary to then have major surgery? This study is looking into a 'wait-and-see' approach for these patients. Instead of going straight to an operation, patients would be carefully watched using regular scans and checks to make sure the cancer hasn't returned or grown back. If the cancer does come back, surgery would then be offered.

Similar studies in other countries have shown that this 'wait-and-see' method might be just as effective as traditional surgery for certain patients, with the added benefit of potentially avoiding an operation and its side effects. This study aims to gather more information in a UK setting to better understand if this approach can safely lead to good long-term outcomes while improving patients' quality of life by reducing the need for major surgery.

Key takeaways

Explores treating rectal cancer with radiotherapy and chemotherapy first.
Aims to see if surgery can be delayed or avoided if the cancer disappears.
Involves very close monitoring with scans and checks if you 'wait and see'.
May help improve quality of life by reducing surgical side effects.
Surgery is still an option if the cancer returns or doesn't clear completely.

Who may be eligible?

To join this study, you need to have a specific type of rectal cancer that shows certain features on your MRI scan, such as how far it has grown or if it affects nearby lymph nodes. You must be generally healthy enough to have cancer surgery if needed, and your routine blood tests (like blood count, liver, and kidney function) need to be within a healthy range. You also need to be 18 years or older and able to understand and agree to take part.

You would not be able to join if you've already had radiotherapy to your pelvis before, or if your cancer has already spread to other parts of your body. Other reasons you might not be suitable include certain heart or lung conditions that aren't well controlled, severe existing bowel problems, or if you've had another cancer recently (other than some very common, easily treated skin cancers or cervical changes). Also, if you are pregnant, breastfeeding, or of childbearing potential and not using effective contraception, you cannot take part.

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.

Do you have rectal cancer?
Has your doctor checked if you are generally fit enough for surgery?
Have you *not* had radiotherapy to your pelvis before?
Is your cancer *not* already clearly spread to other distant parts of your body?
Are you 18 years old or over?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first receive a course of radiotherapy to your pelvis over several weeks, combined with chemotherapy. This treatment aims to shrink or completely get rid of your rectal cancer. After this treatment, instead of immediate surgery, you will be very closely monitored. This will involve regular checks, including special scans and endoscopies (where a thin, flexible tube with a camera is used to look inside your bowel) to see how well the treatment has worked and to check for any signs of the cancer returning.

If the cancer completely disappears after the initial treatment, you will continue to be monitored very carefully with these regular checks. If, at any point, the cancer does not go away completely or if it comes back, you will then be offered surgery. The total duration of your participation will depend on your individual response and how long you are monitored, but it will involve ongoing follow-up appointments over a period of time.

Potential risks and benefits

Potential benefits of taking part include the possibility of avoiding major surgery and its associated complications, which could significantly improve your quality of life while still achieving good cancer control. However, there are potential risks, such as the chance that by delaying surgery, the cancer might grow back or become harder to treat if it's not caught quickly enough. You will be closely monitored to minimise this risk. All treatments have potential side effects, and you will be fully informed about these. Remember, joining any study is completely voluntary, and you are free to withdraw at any time without affecting your standard care.

Locations (2)

McGill University Health Center-Cedars Cancer Centre
Verified postcode
Montreal, Canada· Recruiting
McGill University Health Centre- Cedars Cancer Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is a 'wait-and-see' approach?

It means closely monitoring your cancer after initial treatment with scans and checks, rather than immediately having surgery, especially if the cancer seems to have disappeared.

Will I still get treatment if I 'wait and see'?

Yes, you first receive radiotherapy and chemotherapy. The 'wait-and-see' part refers to delaying or avoiding surgery if the initial treatment is very successful.

What happens if the cancer comes back during the 'wait-and-see' period?

If the cancer shows signs of returning or not disappearing completely, surgery would then be offered to remove it.

Why is this study important?

This study aims to find out if some rectal cancer patients can avoid major surgery, which has significant side effects, while still getting excellent long-term results.

Are there other options besides this study?

Yes, standard treatment for rectal cancer often involves radiotherapy, chemotherapy, and then surgery. Your doctor can discuss all available options with you.

How to find out more

Neil Kopek, M.D.

neil.kopek@muhc.mcgill.ca 514-934-4440 Official trial record

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