
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is comparing a combination of 2 chemotherapy drugs with a combination of 3 chemotherapy drugs for bowel cancer. It is comparing these combinations before and after surgery.
The trial is for people:
Please note, if you aren’t suitable for this trial, you might be able to take part in the FOXTROT 2 trial for bowel cancer. We have a summary of FOXTROT 2 on our trials database.
The main treatment for locally advanced bowel cancer is surgery. You might also have chemotherapy after surgery to kill off any remaining cancer cells.
We know from recent research that giving 2 chemotherapy drugs before surgery works for some people with locally advanced bowel cancer.
Researchers now want to see if a combination of 3 chemotherapy drugs before surgery improves treatment. This combination is called modified FOLFOXIRI. It is already a usual treatment for people whose bowel cancer has spread to other parts of the body.
In this trial, some people have 2 chemotherapy drugs before and after surgery. And some people have 3 chemotherapy drugs before and after surgery.
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 873 people to take part.
Tissue sample testing before treatment
To begin with, the trial team test a sample of cancer tissue from when you were diagnosed. This is to check you have bowel cancer that responds to chemotherapy. They also check if the cancer is on the right side or left side of the bowel.
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. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.
There are 2 groups. You have 1 of the following combinations of chemotherapy:
2 out of every 3 people have FOLFOXIRI. And 1 out of every 3 people have standard treatment.
Everyone has chemotherapy for 6 weeks before surgery. You have treatment in 2 or 3 week . This depends on the combination of chemotherapy you are having.
Modified FOLFOXIRI group (3 drug combination)
You have all your treatment as a drip into your bloodstream. You have modified FOLFOXIRI once every 2 weeks. You have 3 cycles in total before surgery.
Standard treatment group (2 drug combination)
You have one of the following:
Your doctor will talk to you about which treatment option they think will work best for you.
You have OxMdG (FOLFOX) once every 2 weeks. You have 3 cycles in total before surgery.
You have oxaliplatin as a drip into a vein. You have it once every 3 weeks. Capecitabine is a tablet. You take capecitabine twice a day, every day. You have 2 cycles in total.
Surgery
When you finish chemotherapy you have no treatment for 3 to 4 weeks. You then have surgery to remove the cancer. The team talk to you about surgery, what it involves and how long you’ll stay in hospital for afterwards. It will take about a month or two for you to get better after surgery.
More chemotherapy after surgery
The trial team may recommend that you have 6 more weeks of chemotherapy. You have either:
You don’t have to have more chemotherapy if you don’t want to. In some cases, the trial doctor might think you aren’t suitable for further chemotherapy. They will talk to you about this.
Samples for research
The team ask to collect tissue samples when you have surgery. This is to see how well the chemotherapy has worked. They also ask to take extra blood samples. Where possible you have these at the same time as routine blood samples.
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 tests before you can take part. These include:
You have a check up and blood tests before each cycle of chemotherapy. When you finish chemotherapy you have a check up 2 to 4 weeks later to see how you are getting on.
You have another check up:
As part of the trial you have a CT scan 2 to 4 weeks after you finish chemotherapy
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.”