
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is looking at chemotherapy before surgery for bowel cancer to improve treatment.
It is for people who:
The main treatment for bowel cancer is surgery. You might then have chemotherapy to kill off any remaining cancer cells. Sometimes it isn’t possible to have chemotherapy if you are older or you aren’t well enough. This means the cancer is more likely to come back.
Having chemotherapy before surgery is a for some people with some other types of cancer. We know from recent research that giving some chemotherapy first worked for younger, fitter people with bowel cancer. In this trial researchers want to see how well this works for older people or those who are frail.
The main aims of the trial are to:
The following bullet points are a summary of 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.
Who can’t take part
You cannot join this trial if any of these apply. You:
This is a phase 3 trial. The team need to find 759 people to take part.
Tissue sample testing before treatment
The team test a sample of cancer tissue from when you were diagnosed. This is to check that chemotherapy is likely to work for you. They also check if the cancer is on the right side or left side of the bowel. This is because sometimes chemotherapy doesn’t work well for cancer on the right side of the bowel. Your doctor can tell you more about this if it applies.
When they have the results, they’ll let you know if you are suitable for this trial or not.
Trial treatment
This is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
2 out of every 3 people have some chemotherapy first followed by surgery. And 1 out of every 3 people have only surgery.
Surgery
You have surgery to remove the cancer as planned. The team talk to you about what surgery involves and how long you’ll stay in hospital afterwards. It will take about a month or 2 for you to get better. You may or may not have chemotherapy after surgery. This isn’t part of the trial. Your doctor will talk to you about this.
Chemotherapy first followed by surgery (new treatment)
You have chemotherapy for 6 weeks. You have either:
These are the same chemotherapy drugs that you might have after surgery. Your doctor will talk to you about which of the above they think is the best option for you.
In the FOLFOX group you have treatment in. You have all the drugs as a drip into your bloodstream. You have 3 cycles of treatment before surgery.
In the oxaliplatin and capecitabine group you have treatment in 3 week cycles. You have oxaliplatin as a drip into a vein. Capecitabine is a tablet. You take it twice a day, every day. You have 2 cycles of treatment before surgery.
When you finish chemotherapy you have no treatment for 3 to 4 weeks. You then have surgery to remove the cancer. Some people might need to have further treatment after surgery. Your doctor will talk to you about this if they think it is necessary.
Samples for research
The team ask to collect tissue samples when you have surgery. They also ask to take extra blood samples. Where possible you have these at the same time as your routine blood tests.
They plan to use the samples to:
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have some tests before you can take part. These include:
As part of the trial you have a CT scan:
During chemotherapy you see the trial doctor regularly for a check up and blood tests. Everyone has a check up within 12 weeks of having surgery.
Follow up
When you finish treatment you have routine check ups. These include:
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.
The trial doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them any questions you may have.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Jenny Seligmann
University of Leeds
Yorkshire Cancer Research
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”