A study looking at using gene mutations and an enzyme to decide the best treatment for advanced bowel cancer (FOCUS 3)

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer

Status:

Results

Phase:

Phase 2

This study looked at the possibility of using changes in genes and an enzyme to decide the best treatment to give people for advanced bowel cancer.

Doctors usually treat advanced bowel cancer with chemotherapy drugs. They sometimes also use the biological therapy Open a glossary item drugs cetuximab and bevacizumab with chemotherapy. But all drugs have side effects. And some drugs may help some people more than others.

We know from research that if your bowel cancer had a change (mutation Open a glossary item) in a gene Open a glossary item called K-RAS, cetuximab won’t help you. We also know from research that if your bowel cancer has a very low level of an enzyme Open a glossary item called topo-1, you may not need one of the routinely used drugs called irinotecan.

Doctors can do tests to find out the levels of topo-1in a person’s bowel cancer and any changes in their bowel cancer genes. But these tests take time.

Researchers wanted to find out if it was possible to get these test results back and people to be put into a treatment group within 10 working days. They could then work out if it would be useful to set up a much bigger study using test results like this to choose the best treatment for people with advanced bowel cancer.

The aims of this study were to find out

  • How quickly the gene and enzyme tests could be done and people put into a treatment group
  • If it was possible to set up a bigger trial using the results of tests like these to select different combinations of drugs to treat advanced bowel cancer

Summary of results

The trial found that it would be possible to set up a bigger trial using the results of K-RAS and topo-1 testing to select different treatment combinations for advanced bowel cancer.

The trial team sent a sample of the people’s cancer to the laboratory to test for a change in the K-RAS gene and measure the level of the enzyme topo-1.

They then looked at the number of days it took for the results to come back. They found that the results had come back within

  • 10 working days for 71 out of every 100 people (71%)
  • 15 working days for 91 out of every 100 people (91%)
  • 20 working days for 99 out of every 100 people (99%)

The trial team concluded that the time period between getting the results for the K-RAS and topo-1 testing was quick enough to be used to put people into different treatment groups. They have now taken this forward into another clinical trial called FOCUS 4.

We have more information on FOCUS 4.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Tim Maughan

Supported by

Experimental Cancer Medicine Centre (ECMC)
Health and Care Research Wales
Medical Research Council (MRC)
Merck KGaA
NIHR Clinical Research Network: Cancer
Pfizer
Roche

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 4509

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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