A trial of chemotherapy before surgery for bowel cancer in older people (FOXTROT 2)
Cancer type:
Status:
Phase:
This trial is looking at chemotherapy before surgery for bowel cancer to improve treatment.
It is for people who:
- have bowel cancer that has spread into the surrounding tissues (
locally advanced cancer 
) - can have surgery to remove their cancer
- are older, frail or both, or who aren’t very well
More about this trial
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:
- find out if having some chemotherapy before surgery improves treatment for this group of people
- 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 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). - You are having treatment with the aim to cure.
- You have a sample of tissue (
biopsy ) available for the trial team to do some tests on. - Your doctor knows if chemotherapy is likely to work for you. They test a tissue sample to find this out.
- You are fit enough to have 6 weeks of chemotherapy followed by surgery.
- 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 older and or frail or have other health conditions.
Who can’t take part
You cannot join this trial if any of these apply. You:
- are going to have radiotherapy
- are suitable to have a combination of chemotherapy called modified FOLFOXIRI
- 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 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 had
non melanoma skin cancer , carcinoma insitu or an early stage cancer with a low risk of it 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 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:
- surgery (standard treatment)
- some chemotherapy first followed by surgery (new treatment)
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:
- oxaliplatin, folinic acid and fluorouracil 5FU (OxMdG this is also called FOLFOX) or
- oxaliplatin and capecitabine (OxCap or XELOX)
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:
- look at
genes in bowel cancer cells - see if it is possible to predict who benefits from having chemotherapy before surgery
- test new ways of monitoring the 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 some tests before you can take part. These include:
- blood tests
- a
physical examination - CT scan
As part of the trial you have a CT scan:
- 2 to 4 weeks after finishing chemotherapy if you had it
- 3 years after joining the trial
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:
- 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
