
“I think it’s essential that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing 2 ways of giving an increased dose of radiotherapy before surgery for rectal cancer. It is open to people with cancer of the back passage (rectum) that can be removed by surgery.
The standard treatment for rectal cancer is to have surgery to remove the rectum.
Another treatment doctors might use is chemoradiotherapy. You have 5 weeks of radiotherapy to the area between your hips (pelvis) along with a chemotherapy tablet twice a day.
After chemoradiotherapy if there is no sign of the cancer (a complete response) you might not need to have surgery. Or if you still need surgery it might not mean removing the rectum. Unfortunately after chemoradiotherapy a complete response is rare.
Studies have shown that increasing the amount of radiotherapy can increase the chances of a complete response. This can be done by giving extra doses of radiotherapy after the 5 weeks. This is called a boost.
In this trial researchers want to compare 2 ways of giving a boost of radiotherapy:
The aims are to:
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:
You cannot join this trial if any of these apply. You:
This is an international European phase 3 trial. The team need 236 people in Europe to join the trial, 120 from the UK.
Everyone has chemoradiotherapy followed by a boost (extra doses) of radiotherapy. For chemoradiotherapy you have capecitabine at the same time as your radiotherapy.
Capecitabine is a tablet you take twice a day when you have radiotherapy.
You have 5 weeks of radiotherapy Monday to Friday.
The boost part of the trial is randomised. You are put into 1 of 2 groups by a computer. Neither your or your doctor can choose which group you are in.
Everyone taking part has chemoradiotherapy followed by one of the following:
During the 14th week after starting chemoradiotherapy your doctor will assess how well the cancer has responded to treatment. The response can be either:
Whether you need further treatment depends on the response. Your doctor will talk to you about this.
For a complete response or almost complete response
You might have:
For partial response and stable disease
It is recommended you have surgery to remove the rectum. You have the surgery about 3 weeks after seeing the doctor for the assessment.
Quality of life
You fill in a quality of life questionnaire:
The questions ask you about:
You see the doctor before taking part to have the following tests:
During treatment you see the doctor every week to see how you are. People having the 3 extra doses of internal radiotherapy also have a rectal examination during their boost.
You see the doctor 14 weeks after starting treatment to assess how well the cancer responded to treatment. And to talk about further treatment.
You then see the doctor:
The most common side effects of radiotherapy are:
The most common side effects of capecitabine are:
Your doctor will talk to you about the side effects of treatment before you agree to take part.
We have information about the side effects of radiotherapy for rectal cancer and capecitabine.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Arthur Sun Myint
Centre Antoine-Lacassagne, France
Freephone 0808 800 4040
“I think it’s essential that people keep signing up to these type of trials to push research forward.”