"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at different treatments for different types of bowel cancer (FOCUS4)
More about this trial
If bowel cancer cannot be completely removed with surgery, or has spread to another part of your body, you are likely to have chemotherapy. We know from research that for most people it is safe to have a break from chemotherapy after a few months.
In this trial, researchers want to see if having other treatment during this chemotherapy break helps to extend the time before bowel cancer starts growing again. Not all bowel cancers are the same and some new cancer drugs may help people with one type of bowel cancer more than another.
To work out the subtype of bowel cancer you have, the researchers will test a sample of your cancer to look for changes to certain genes and proteins that your tumour produces.
If you agree to have a sample of your cancer tested, and your cancer doesn’t get any bigger during chemotherapy, you can enter the part of the trial testing new treatments. The researchers will look at a number of different treatments. They call these comparisons.
Please note – at present, only 2 of the comparisons are recruiting people. These are called FOCUS4-C and FOCUS4-N.
Who can enter
- have a type of cancer called adenocarcinoma that started in the large bowel (colon) or back passage (rectum)
- have cancer that cannot be removed with surgery or has spread to another part of your body
- have cancer that can be measured on a CT scan, and a sample of your cancer taken before you started chemotherapy that can be tested to look for proteins and gene changes
- are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- had a CT scan in the 6 weeks before you started chemotherapy and the results of the scan are available electronically
- are at least 18 years old
- are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
- you must have a change to genes called KRAS/NRAS and p53 or loss of the H3K36me3 protein (your doctor can tell you more about this)
- your cancer has stayed the same size or got smaller after having 16 weeks of chemotherapy
- you have had a CT scan in the last 4 weeks that confirms this
- have satisfactory blood test results and organ function
- your cancer must have stayed the same size or got smaller after having 16 weeks of chemotherapy
- you have had a CT scan in the last 4 weeks that confirms this
- have satisfactory blood test results
- have cancer that has spread to your brain
- have previously had chemotherapy for advanced bowel cancer
- have had chemotherapy after surgery to try to stop your cancer coming back (
adjuvant treatment) in the last 6 months
- are pregnant or breastfeeding
- have HIV
- have hepatitis B or hepatitis C
- still have moderate or severe side effects from previous treatments, apart from hair loss (alopecia) and loss of appetite
- can’t swallow tablets
- have a serious infection or any other medical problem that the trial team think could affect you taking part
- have heart problems such high blood pressure, angina that isn’t controlled, congestive heart failure or a condition called Torsades de pointes
- have stomach problems such as an ulcer, unless you have had an operation to remove it or it has been stable for the past 6 months
- have had bleeding in your gut unless this has been surgically removed
- have had a major operation in the last month, or a small surgery in the past week
- are taking drugs called CYP3A4 such as erythromycin, verapamil or nefazodone and you can’t stop it during this trial
- are taking certain drugs such as aprepitant, atorvastatin or simvastatin and are not able to stop or substitute these 2 weeks before starting trial treatment
- are taking herbal remedies and are not able to stop or substitute these 1 week before starting trial treatment
- are taking St John’s Wort and are not able to stop or substitute this 3 weeks prior to starting trial treatment
- can’t take capecitabine for any reason
- have had any other chemotherapy treatment for your bowel cancer apart from the 16 weeks of chemotherapy you have just had
- are going to have a combination of chemotherapy and radiotherapy for rectal cancer (you can take part in you’re having radiotherapy for symptoms)
- have high blood pressure that can’t be well controlled or certain heart problems
- are taking part in any other trial looking at treatment for people in your situation, if this would cause problems with you taking part in the FOCUS4-N
- the comparison called FOCUS4-A is for cancer with a change (mutation) to a gene called BRAF
- the comparison called FOCUS4-B is for cancer with a change to a gene called PIK3CA or that only produces a small amount of a protein called PTEN
- the comparison called FOCUS4-C is for cancer with a change to genes called KRAS or NRAS in combination with a change to the gene called p53 OR there is a loss of the H3K36me3 protein in the cancer
- the comparison called FOCUS4-D is for cancer that doesn’t have changes to any of these genes
- the comparison called FOCUS4-N is for cancer that cannot be classified as any of the subtypes above or for people that do not wish to enter any of the comparisons above
- no further treatment until scans show that your cancer is growing again (active monitoring)
- capecitabine tablets twice each day for 2 weeks out of every 3
- no further treatment until scans show your cancer is beginning to grow again (active monitoring)
When you join the trial, the researchers will test a sample of your cancer that had already been removed. If you enter the FOCUS4-C comparison they will ask you to consider having 2 new
They will want to get a new biopsy sample before you start one of the trial treatments and another one at the end of the trial treatment. These biopsies are optional. If you don’t want to give these samples for research, you don’t have to. You can still take part in the main trial.
You see the trial team and have blood tests regularly during the trial. How often you go to hospital, and the tests you need to have depends on which comparison you are in.
If you are in FOCUS4-C you see the trial doctor every 3 weeks for blood tests and a physical examination. You also have a CT scan every 7 to 9 weeks.
If you are in FOCUS4-N, you see the trial doctor every 3 to 4 weeks and have a CT scan every 7 to 9 weeks.
The trial team will ask people who join FOCUS4-N to fill out a questionnaire before they start treatment, every 8 weeks during treatment and after they finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Whichever comparison you join, when you finish the trial treatment, you see the trial team again within 4 weeks, then after 3 months and then every 6 months after that.
How to join a clinical trial
Professor Tim Maughan
Professor Richard Wilson
Cancer Research UK
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
NIHR Efficacy and Mechanism Evaluation (EME) Programme
University College London (UCL)
University of Belfast
University of Leeds
University of Oxford
The Trial is funded jointly by Cancer Research UK and the Medical Research Council (MRC)/National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme.
This is Cancer Research UK trial number CRUK/11/054.