Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study looking at chemotherapy and surgery for bowel cancer that has spread to the liver (EPOC B)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at the best way to have chemotherapy and surgery for bowel cancer that has spread to the liver. This trial is supported by Cancer Research UK.
Doctors usually treat bowel cancer that has spread to the liver with chemotherapy followed by surgery to remove the cancer in the liver (
Having chemotherapy before surgery can increase the risk of side effects of surgery. But doctors know that chemotherapy is the best chance of keeping the cancer at bay.
In this study doctors are looking at giving all the chemotherapy after surgery. They hope this will reduce the risk of surgery side effects.
The aims of the trial are to find out
- If having all the chemotherapy after surgery is better than the standard treatment
- About the side effects
- If people with bowel cancer that has spread to the liver want to take part in the trial
Who can enter
You may be able to enter this trial if you
- Have bowel cancer in the liver (
liver metastases) that can be removed with surgery
- Have satisfactory blood test results
- Have cancer that can be measured on CT scan
- Are well enough to have surgery and chemotherapy
- Are well enough to be up and about for at least half the day (performance status 0, 1, or 2)
- Are willing to use reliable contraception while you are having the trial treatment and for 3 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have bowel cancer that has spread anywhere other than your liver
- Have already had chemotherapy for bowel cancer that has spread (metastatic bowel cancer)
- Have had chemotherapy in the last 6 months
- Are taking drugs to damp down your
- Have had surgery for bowel cancer in the liver in the last year
- Have had chemotherapy and radiotherapy (chemoradiotherapy) in the last month
- Need treatment other than chemotherapy and surgery
- Have any medical condition that is a cause for concern
- Have a completely or partly blocked bowel (bowel obstruction)
- Are taking any medication that interferes with the trial drugs - your doctor will discuss this with you
- Have frequent diarrhoea or inflammatory bowel disease
- Have or have had any other cancer that may affect the results of the trial - your doctor will discuss this with you
- Are known to be allergic to any of the drugs used in the trial
- Have a condition called DPD deficiency (which means you cannot have certain types of chemotherapy)
- Have any other medical condition that would affect you taking part in the trial
- Are pregnant or breastfeeding
This is a pilot study. It will recruit about 78 people across the UK. If the results are promising, it will recruit more people into a larger trial.
This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1, you will have chemotherapy before and after surgery to remove cancer in your liver.
If you are in group 2, you will have surgery to remove cancer in your liver, followed by chemotherapy.
You have CAPOX once every 3 weeks. You have FOLFOX and FOLFIRI once every 2 weeks. Each 2 or 3 week period is called a cycle of treatment. Both groups have a total of 24 weeks of chemotherapy.
You fill out a questionnaire before you start treatment, after 6, 12, 24 and 32 weeks, then every 3 months for 1 year and every 6 months for 3 years. The questionnaire will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.
The researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. They will also ask you for blood samples. These blood and tissue samples will help researchers to find out more about bowel cancer and the best way to treat it in the future.
If you do not want to give tissue samples for this study, you don’t have to. You can still take part in the trial.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan
Day 1 of each cycle of chemotherapy you will have
- Physical examination
- Blood tests
Once you have finished the chemotherapy you will be seen for a physical examination, CT scan and blood tests every
- 3 months for 2 years
- 6 months for 3 years
The most common side effects of the 3 different chemotherapy treatments in this trial are
- Feeling or being sick
- Tiredness (fatigue)
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- A skin rash
People who have FOLFIRI treatment may have hair loss.
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.
Professor John Primrose
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
This is Cancer Research UK trial number CRUK/06/031.