A trial looking at follow up after colorectal (bowel) surgery (FACS)

Please note this trial is no longer recruiting patients.

The aim of this study is to find the best way to follow up patients after treatment for bowel cancer.

Bowel (colorectal) cancer can often be cured with surgery, chemotherapy and radiotherapy. But sometimes it can come back (recur). Some specialists see their patients regularly after treatment has finished, but some do not. Follow up varies a lot between different hospitals, and doctors are not sure what is best.

More regular follow up may help the doctors to diagnose a recurrence of bowel cancer earlier. But having regular tests can be stressful for patients. And there is limited evidence so far that diagnosing a recurrence of bowel cancer earlier will improve survival rates.

Recruitment

Start 01/01/2003

End 14/08/2009

Phase

Phase 3

Who can enter

You can enter this trial if you have

Been diagnosed with bowel cancer that has not spread (Dukes' A or Dukes' B), or that has spread to the lymph nodes (Dukes' C)
Bowel cancer that has been successfully treated (cured) with surgery, chemotherapy or radiotherapy
Had surgery to remove bowel cancer in the last 6 months (or in the last 12 months if you had chemotherapy as well as surgery)

You cannot enter this trial if you have

Been diagnosed with bowel cancer that has spread to another part of the body (Dukes' D)
Bowel cancer that has not been successfully treated
Any other serious medical condition
Familial adenomatous polyposis (FAP)

Trial design

This is a randomised trial. There are 4 groups. The people taking part are put into the different groups by a computer. Neither you nor your doctor will be able to decide which group you are in. The trial will recruit about 1,000 patients.

The follow up you will receive will vary, depending on which trial group you are in.

Group 1 You may have a CT scan between 12 and 18 months after you join the trial. And you will have a colonoscopy after 5 years. Apart from that you will not have any tests unless you develop symptoms that may be caused by a recurrence of your bowel cancer. Your doctor will talk to you about what symptoms to look out for.

Group 2 You will have a CEA blood test every 3 months for 2 years, and then every 6 months for another 3 years. If the test result is high, it will be repeated. This is because a rise in the level of CEA in your blood can be caused by problems that are not bowel cancer. The CEA level may go back to normal without treatment. If it stays high, you will have further tests to find out why. You may have a CT scan between 12 and 18 months after you join the trial. You will also have a colonoscopy after 5 years.

Group 3 You will have a CT scan every 6 months for 2 years and then every year for another 3 years. You will also have a colonoscopy 2 years and 5 years after your operation. If your scans show anything abnormal, you will have further tests.

Group 4 You will have regular blood tests (as for group 2) and scans (as for group 3), and a colonoscopy 2 years and 5 years after your operation. If your tests show anything abnormal, you will have further tests.

No matter which group you are in, if you develop symptoms that you think may be caused by a recurrence of your bowel cancer, you should go and see your doctor.

You will be asked to fill out a questionnaire once a year while you are taking part in this trial. The questionnaire will ask you how you have been feeling. This is called a ‘Quality of Life’ study.

The trial doctors will also ask you if they can take a blood sample and a sample of your cancer. The samples will not be used straight away, but will be stored. They may be used to find out more about bowel cancer in the future. You don’t have to take part in this part of the trial.

Hospital visits

If you are in group 1, you will only have to make one or two extra trips to hospital as a result of taking part in this trial. One is to have a colonoscopy and the other is for a CT scan (if you have one).

But if you are in groups 2, 3 or 4 you will have extra tests as described above. The blood tests can be done at your family doctor’s (GP’s) surgery. The CT scans and colonoscopies will be done at the hospital. You can have them all as an outpatient.

If any of your test results are abnormal you will have more tests to find out if your cancer has come back or not. If your cancer has come back, your specialist will discuss the treatment options with you.

Side effects

There are few side effects associated with this trial. You may find the blood tests a bit sore.

You will be exposed to a very small amount of radiation if you have CT scan, but this is not dangerous. There is more information about having a CT scan in the main section of CancerHelp UK.

If you have a colonoscopy you may find it uncomfortable and a bit embarrassing. There is a small risk of damage to your bowel, but this is rare.