A trial looking at treatments for different types of bowel cancer (FOCUS4)

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer

Status:

Results

Phase:

Phase 2/3

This trial looked at different treatments for certain types of bowel cancer. It was for people with bowel cancer that couldn’t be removed with surgery or had spread to another part of the body.

The trial was open for people to join between 2014 and 2020. The team have published several results papers in different medical journals.

More about this trial

Doctors usually use chemotherapy to treat bowel cancer that has spread or can’t be removed with surgery.

When this trial was done, people often had chemotherapy for about 4 months. Then they had a break from treatment for a while.  Researchers wanted to find out if it was useful to have other treatment during this break from chemotherapy.

This trial had 5 treatment groups. Each group was for people with different types of bowel cancer. The treatment people had depended on the genetic changes in the cancer.

FOCUS4-A was for people with a change to the BRAF gene. It was due to look at a combination of treatment but didn’t open. 

FOCUS4-B was for people with a change to the PIK3CA gene and looked at aspirin. It was closed much earlier than planned, so there are no results for this part of the trial.

FOCUS4-C was for people with a change to the KRAS or NRAS gene and a change in the TP53 gene. It looked at a targeted treatment called adavosertib (AZD1775). There is a summary of results in the section below.

FOCUS4-D was for people who didn’t have changes to the BRAF, PIK3CA, KRAS or NRAS genes. It looked at a targeted treatment called sapitinib (AZD8931). There is a summary of the results in the section below.
 
FOCUS4-N was for people who either didn’t have genetic analysis results, or didn’t want to enter one of the groups above. It looked at a chemotherapy drug called capecitabine. There is a summary of the results in the section below.

The main aim of this trial was to find out if having a different treatment after 4 months of chemotherapy can help stop bowel cancer coming back. The team used genetic analysis to decide which group people should be in.

Summary of results

Trial design
This trial was for people who:

  • had bowel cancer that had grown outside the bowel or had spread to another part of the body (advanced cancer)
  • had not had treatment for advanced cancer before
  • were not able to have an operation to remove their cancer 

They were all due to have chemotherapy.

A total of 361 people had treatment in 1 of 4 groups. The group they were in depended on the results of genetic analysis. There were:

  • 6 people in FOCUS4-B (there are no results for this part of the trial)
  • 69 people in FOCUS4-C
  • 32 people in FOCUS4-D
  • 254 people in FOCUS4-N

Within each of these main groups, people were put into 1 of 2 treatment groups at random. There is more detail about each group below.

Results

FOCUS4-C
There were 69 people in this part of the trial:

  • 44 people had adavosertib
  • 25 people had regular tests and check ups (active monitoring)

The team looked at how long it was before people’s cancer started to grow again. They found it was:

  • 3.6 months for those who had adavosertib
  • 1.9 months for those who had active monitoring

When they looked at how long people lived, they found it was similar in the two groups.

Everyone taking part had at least one side effect of treatment. Most were mild or didn’t last long, but some were more severe. The most common of the more severe side effects were diarrhoea, feeling sick and a drop in white blood cells.

They concluded that adavosertib could be a useful treatment for this group of patients. They suggest larger trials are done to find out more.

FOCUS4-D
There were 32 people in this part of the trial:

  • 16 had sapitinib
  • 16 had a dummy drug (placebo)

The research team looked at the results part way through. This is called an interim analysis. They found that there was little difference between the two groups. So they decided to close FOCUS4-D.

When they looked at how long it was before the cancer started to grow, they found it was:

  • 3 months for those who had sapitinib
  • 3.5 months for those who had a dummy drug (placebo)

As with FOCUS4-C, most of the side effects were mild. The most common of the more severe side effects of sapitinib was a rash.

The team concluded that this trial didn’t show that sapitinib was a useful treatment for this group of patients. 

FOCUS4-N
There were 254 people in this part of the trial:

  • 127 had capecitabine
  • 127 had regular tests and check ups (active monitoring)

The team looked at how long it was before people’s cancer started to grow. They found it was:

  • 3.9 months for those who had capecitabine
  • 1.9 months for those who had active monitoring

When they looked at how long people lived, they found there was no difference between the groups.

The side effects of capecitabine were as expected. The most common ones were extreme tiredness, diarrhoea and redness on hands and feet. 

The team concluded these results suggest having a break from chemotherapy doesn’t affect how long people live. They also suggest that capecitabine could be used to give people a longer break before re-starting other chemotherapy.

More detailed information
There is more information about this research in the references listed on the website below. 

Please note, the articles included in the link below are not in plain English. They have been written for health care professionals and researchers.

http://www.focus4trial.org/focus4-news/

Where this information comes from    
We have based this summary on the information in the articles above. These have been reviewed by independent specialists (peer reviewed) Open a glossary item and published in medical journals. 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
Professor Richard Wilson

Supported by

AstraZeneca
Bayer
Cancer Research UK
Cardiff University 
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

Other information

The Trial was jointly funded 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.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9181

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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