A trial comparing 2 combinations of chemotherapy for bowel cancer (FOXTROT 3)
Cancer type:
Status:
Phase:
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:
- whose cancer has grown into surrounding tissue (
locally advanced cancer 
) - who can have surgery to remove the cancer
- who are well enough to have the combination of 3 chemotherapy drugs
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.
More about this trial
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:
- find out which combination of chemotherapy works best
- learn more about the side effects
- see how treatment affects quality of life
Who can enter
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.
- You have
adenocarcinoma of the colon or upper rectum or you have bowel cancer cells that look very abnormal under the microscope and have grown into surrounding tissues. - You have cancer that has grown into the outer lining of the bowel wall or further. It may or may not have spread into lymph nodes but it hasn’t spread to other parts of the body. (This is stage T3-4, N0-2, M0 bowel cancer).
- You have a sample of tissue (
biopsy ) available for the trial team to do some tests on. - You are suitable to have modified FOLFOXIRI. Please note, most people who are suitable to have FOLFOXIRI will be aged under 70 years.
- If you have cancer on the right side of your bowel your doctor knows if chemotherapy will work for you.
- You have satisfactory blood test results.
- You are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant.
- You are at least 18 years old.
Who can’t take part
You cannot join this trial if any of these apply. You:
- are going to have radiotherapy
- might have cancer that has spread to other parts of the body or into the
lymph nodes in the peritoneum - have a blockage in your bowel
- have a severe inflammatory bowel disease
- have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) bowel cancer. Your doctor will know this.
- are allergic to any of the chemotherapy drugs in the trial
- have tingling or numbness in your hands or feet and this causes significant problems with activities of daily living
- have a
DPD deficiency - have had recent treatment with brivudine, sorivudine or a similar drug
- had another cancer in the last 5 years. You can join if you have
non melanoma skin cancer , carcinoma insitu or any early stage cancer with a low risk of coming back - are pregnant or breastfeeding
- have any other serious medical condition or mental health problem that the trial team think could affect you taking part
Trial design
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:
- modified FOLFOXIRI – this includes the drugs folinic acid, fluorouracil (5FU), oxaliplatin and irinotecan.
- OxMdG (FOLFOX) or oxaliplatin and capecitabine (standard treatment)
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:
- OxMdG (FOLFOX). This includes the drugs folinic acid, fluorouracil (5FU) and oxaliplatin
- oxaliplatin and capecitabine
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:
- the 3 drug combination (modified FOLFOXIRI) or
- the 2 drug combination (standard treatment)
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:
- look at
genes in bowel cancer cells - see if it is possible to predict who benefits most from the different combinations of chemotherapy
- test new ways of monitoring your cancer after surgery
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- at set times during treatment
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study
Hospital visits
You see the doctor and have tests before you can take part. These include:
- blood tests
- a
physical examination - CT scan
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:
- about 2 to 4 weeks after surgery
- within 3 months of surgery. This is so the team can assess if you are suitable to have more chemotherapy.
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:
- blood tests every 6 months for 3 years
- a CT scan every year for 3 years
Side effects
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:
Location
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
Dr Jenny Seligmann
Supported by
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
