
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This is a trial comparing the standard dose of radiotherapy with a higher dose of radiotherapy for small cancers of the back passage (rectum). It is for people having radiotherapy or chemoradiotherapy who are not having surgery.
The usual treatment for people with small (early) cancers of the rectum is surgery. But some people aren’t able to have surgery. These people have either radiotherapy on its own or a combination of chemotherapy and radiotherapy (chemoradiotherapy).
Researchers think that a higher dose of radiotherapy might be better than the . To find this out they need to compare people who have the standard dose of radiotherapy with people who have the higher dose.
In this trial some people will have either:
The aims of this trial are to find out:
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.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
You cannot join this trial if any of these apply. You:
This is a phase 2 trial. The team need 104 people to join.
This is a randomised trial. You go into treatment groups. Neither you nor your doctor chooses which group you are in.
The treatment groups for people having chemoradiotherapy are:
The treatment groups for people having radiotherapy are:
Out of every 3 people who join the trial, 2 will have the higher dose of radiotherapy.
Before your radiotherapy you have a planning appointment. This is to work out where to give the radiotherapy.
You have (IMRT). IMRT targets the cancer more precisely. This means the cancer gets a higher dose of radiotherapy and the surrounding healthy tissue gets a much lower dose of radiotherapy.
You have treatment Monday to Friday once a day for 5½ weeks (28 days).
People having chemoradiotherapy have either capecitabine or fluorouracil (5FU). Your doctor will talk to you about what is the best chemotherapy for you.
Capecitabine is a tablet. You take it twice a day on the days you have radiotherapy. You have a diary to write down how many tablets you take and when you take them.
You have 5FU as a drip into a vein. You have it once a day during the first 5 days of radiotherapy. You have it again during the last full week (days 21 to 25) of your radiotherapy.
Quality of life
You fill in 3 questionnaires:
The questions ask about:
This is a quality of life questionnaire.
Extra research
The team will ask to use the information from your radiotherapy and any scans you have along with the tissue sample from when you were diagnosed. They will use this to look at the of the cancer cells to find out whether they can predict who might benefit from having the higher dose of chemoradiotherapy.
They might ask you to fill in a short questionnaire about people’s preference for cancer treatment.
You don’t have to agree to sharing your information or doing the questionnaire. You can still take part in the trial.
You see the doctor for some tests before taking part. These tests include:
You see the doctor every week during treatment and at the end of treatment. This is for blood tests and to see how you are.
You will get a phone call from the team 2 weeks after treatment to see how you are.
After treatment you see the doctor at:
You have an MRI scan at:
You have a flexible sigmoidoscopy at:
Your doctor may decide that you should have additional scans or examinations. They will not be part of the trial.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Having the higher dose of radiotherapy might make the side effects worse.
Radiotherapy has early side effects and late side effects.
Early side effects can happen during radiotherapy and for a few weeks after. These include:
Late side effects of radiotherapy can happen months or years after treatment. These include:
We have information on:
Your doctor or a member of the trial team will talk to you about the possible side effects of treatment before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Simon Gollins
Dr Ane Appelt
University of Leeds
Yorkshire Cancer Research
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.