A trial looking at the timing of surgery after treatment for rectal cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer

Rectal cancer

Status:

Closed

Phase:

Other

This trial is looking at whether it is safe to delay surgery after chemoradiation for cancer of the back passage (rectum). This trial is supported by Cancer Research UK.

More about this trial

Doctors usually treat rectal cancer with chemotherapy and radiotherapy together. This is called chemoradiation. They then do an operation to remove the cancer about 6 to 8 weeks later. But researchers have found that the cancer goes away completely for 1 out of 7 people who have chemoradiation. So these people don’t benefit from having the operation.

We also know from research that chemoradiation can carry on working for longer than 6 to 8 weeks. So the cancer could continue to get smaller or go away completely if we waited a bit longer after treatment. If this happens, people could avoid surgery or have a smaller operation.

The aim of this trial is to see if it is safe to delay or avoid major surgery after chemoradiation.

Who can enter

You can enter this trial if you

Have rectal cancer
Have had chemoradiation and MRI scans have shown that your cancer is responding well to treatment (you may have also had chemotherapy alone)
Are due to have an operation
Are well enough to be up and about for at least half the day
Are at least 18 years old

You cannot enter this trial if you

Have stage 4 rectal cancer that has spread to another part of your body
Have had MRI scans after chemoradiation that show your cancer is not responding to treatment
Have already had radiotherapy alone
Have a rare type of cancer called mucinous rectal cancer
Are not able to have an MRI scan (if you have a pacemaker or metal plate in your body, for example)
Are pregnant or breastfeeding

Trial design

Everyone taking part in this trial will have chemoradiation as usual. Four weeks after that you will have an MRI scan.

If the scan shows your cancer has gone completely, you will not have surgery. You will have another scan at 8 to12 weeks, just to be sure. You then start the follow up programme and have regular scans and tests. There are more details about this in the ‘hospital visits’ section below.

If the MRI scans show that your cancer has stayed the same or continued to grow, you will go ahead and have the operation.

You will fill out a questionnaire at various times during the trial. It will ask you how you have been feeling and about any side effects you have had. This is called a quality of life questionnaire

The research team would like to use some of the cancer that was removed when you had your biopsy. This is so they can find out more about rectal cancer and how it responds to treatment. But this is optional. You can still take part in the trial if you decide not to agree to this.

Hospital visits

If the MRI scans show that your cancer has gone, you will have regular tests and scans for 10 years to look for any signs that your cancer has come back again. This is so the doctors can be sure that it’s safe to decide not to operate. If there are any signs that your cancer has come back, you will have surgery to remove it.

You will have

3 CT scans in the first 3 years
8 MRI scans in the first 2 years, and one every year for 5 years
3 PET scans in the first year
5 sigmoidoscopies using a flexible tube (a ‘flexi sig’) in the first 2 years, and then at 3, 4, 6 and 7 years
A colonoscopy at 1, 5 and 10 years

You will also see the doctors at the outpatient clinic 4 times in the first 6 months, then every 3 months for 18 months, then every 6 months for 3 years and then once a year for 5 years.

This may seem a lot, but it’s important to be sure that there are no signs of the cancer growing again.

Side effects

There are no extra treatments in this trial, so there are no treatment side effects.

You will have more CT scans, MRI scans, PET scans and sigmoidoscopies than usual if you take part in this trial. These tests are generally very safe, but there is more information about the possible risks on the links above.

If the chemoradiation works and you don’t need to have an operation, you will avoid the possible side effects of surgery for rectal cancer.