A trial looking at surgery alone for people with rectal cancer (SAILOR)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is for people who have a cancer low down in their bowel (rectum) that can be removed by surgery.
Cancer Research UK supports this trial.
More about this trial
Radiotherapy followed by surgery is the usual treatment for people with rectal cancer. Radiotherapy is given before surgery as it can shrink the cancer and make it easier to remove.
Doctors are not sure if radiotherapy is necessary for everyone. For some people the treatment might have no added benefit and they would do just as well having only surgery. But doctors need to know this for sure.
In this trial doctors want to compare 2 groups.
- One group have radiotherapy followed by surgery (
standard treatment 
) - The other group have surgery straight away
This is a feasibility trial. This is designed to see if a larger trial can be done. The aims of this trial are to find out:
- whether people would be willing to be put into groups at random (
randomisation ) - how many people would be needed in a larger trial
- if medical staff are likely to ask people to take part in a larger trial
- why people might not want to take part in this type of trial
If a larger trial looking at surgery alone is possible, the doctors will look to do one in the future.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply.
- You have been diagnosed with an adenocarcinoma of your rectum
- Your cancer is low down in your rectum and you need to have an operation to remove your rectum and anus (back passage). This might be an abdominoperineal excision of the rectum (APER) or a low anterior resection (LAR)
- You have a cancer that can be seen and measured on a scan or by the doctors
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment if there is any possibility you or your partner could become pregnant
- You are aged 18 years or older
You cannot join this trial if any of these apply.
- Your doctors think you should have radiotherapy before surgery
- You have a very early stage cancer (T1 or T2) and the cancer has not spread to your
lymph nodes - Your cancer is larger than 5 mm (clinical stage T3 c or d)
- Your cancer has spread to other organs (such as the prostate gland or to the bones at the base of your back called the sacrum or coccyx) and you need to have a bigger operation
- Your cancer has spread locally such as into the muscles controlling the opening and closing of your anus (anal sphincter) or the cancer can be seen outside of your anus
- Your cancer has spread elsewhere in your body (T4) and you can’t have surgery to remove it
- Your cancer has caused a hole (a fistula) between your rectum and another part of your body such as your vagina or the skin around your back passage
- The lymph nodes in the area between your hip bones (pelvis) or in the area between a large vein called the aorta and the lower part of your spine are swollen
- You have another type of cancer that is currently active and your doctors think it will affect you being able to take part in this trial
- You have had any other cancer in the last 5 years unless it was very early stage
- You have had radiotherapy to your pelvis
- You have had chemotherapy in the last 5 years
- You are not able to have surgery for any reason
- You are not able to have an MRI scan - this could be because you have metal clips or a pacemaker in your body, or you cannot cope with small spaces, or your kidneys do not work well enough to flush through the MRI
contrast - You are not able to have chemotherapy for any reason
- You have any serious medical condition or mental health problem that the trial team think could stop you taking part
- You are pregnant
Trial design
This is a feasibility trial. Doctors need about 80 people to take part.
It is a randomised trial. Everyone taking part is put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- One group will have radiotherapy followed by surgery
- The other group will have surgery straight away
Your doctor will tell you which group you are in. If you aren't happy with the group talk to your doctor as it can be changed.
The type of surgery you have depends on the stage of your rectal cancer. Your operation will be the same, whether you take part in this trial or not. This is the same for both groups.
You might have an abdominalperineal excision of the rectum (APER). This involves removing your rectum and anus. You then have a permenant colostomy bag.
You might have a low anterior resection (LAR). This involves removing your rectum and joining the bowel back together. You usually have a temporary colostomy bag for a short while after this operation.
Radiotherapy and surgery
You have radiotherapy Monday to Friday for 5 weeks (25 treatments).
You might also have chemotherapy. You usually have this as a tablet that you take every day. Your doctor will tell you if you need this.
About 6 weeks after finishing treatment you have a scan to see how well the radiotherapy has worked. And to help your doctor plan your surgery.
You then have your operation about 8 to 12 weeks after completing radiotherapy. This allows time for the radiotherapy to work and for you to recover from any side effects.
You might also have chemotherapy after your surgery. Again your doctors will tell you if you need this.
Surgery alone
After your operation, you might have chemotherapy or radiotherapy or both. Your doctors will tell you if you need additional treatment.
Quality of life
The trial team ask you to fill out some questionnaires before your surgery and then after your operation at
- 1 month
- 3 months
If you are in the group having radiotherapy you are also asked to complete a questionnaire during your final radiotherapy visit.
The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctors and have some tests before either your radiotherapy or surgery. The tests include:
- blood tests
- a heart trace (
ECG )
If you are in the group having radiotherapy your treatment will be planned first.
You go to hospital for your radiotherapy. The actual treatment only takes a few minutes. But getting you into position can take a bit longer.
Your doctor will tell you how long you will be in hospital for your surgery. It is usually for 7 to 10 days.
You see the doctors after your surgery at
- 1 month
- 3 months
Side effects
The side effects of radiotherapy to your bowel include:
- tiredness
- diarrhoea
- feeling sick
- passing urine more often
- sore skin around your anus
We have more information about the side effects of radiotherapy to the bowel.
We also have information on
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Dean Harris
Supported by
Bowel Disease Research Foundation
Cancer Research UK
NIHR Clinical Research Network: Cancer
Swansea Trials Unit
Swansea University
Other information
This is Cancer Research UK trial number CRUKE/14/050
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
