A trial looking at chemotherapy with or without cetuximab for bowel cancer that has spread to the liver, but can be removed surgically (New EPOC)

Cancer type:

Bowel (colorectal) cancer
Cancer spread to the liver
Secondary cancers

Status:

Results

Phase:

Phase 3

This trial was looking at chemotherapy with or without cetuximab for advanced bowel cancer. The trial was supported by Cancer Research UK.

Advanced bowel cancer means the cancer has spread from where it started in the bowel or back passage to another part of your body. Bowel cancer may be advanced when it is first diagnosed. Or it may come back some time after you are first treated.

If bowel cancer spreads, it often goes to the liver. It may be possible to have surgery to remove secondary cancer from the liver. People who are able to have this type of surgery may have chemotherapy as well.

In this trial, researchers were looking at giving cetuximab (Erbitux) as well as chemotherapy. Cetuximab is a type of biological therapy called a monoclonal antibody.

Cetuximab could already be used alongside chemotherapy for people who had bowel cancer that had spread to the liver if doctors thought this would enable the patient to have a liver operation. But this trial tested it in people who had cancer spread to the liver who were suitable for surgery.

The aims of this trial were to

  • Find out if cetuximab and chemotherapy together worked better than chemotherapy alone as a treatment in addition to surgery for people with bowel cancer that had spread to the liver but could be removed with surgery
  • Learn more about the side effects

Summary of results

The researchers found that adding cetuximab to chemotherapy did not help this group of people.

The trial recruited 272 people who had bowel cancer that had spread to their liver and were well enough to have chemotherapy and surgery to remove the secondary cancer.

Some advanced bowel cancers have a change to a gene called K-RAS. We know from research that cetuximab doesn't help people who have this gene change. So the people in this trial all had cancers with a normal K-RAS gene.

The trial was randomised. The people taking part were put into 1 of 2 groups by computer. Neither they nor their doctors could decide which group they were in. The treatment plan for people in one group was to have12 weeks of chemotherapy before surgery and another 12 weeks afterwards. The treatment plan for people in the other group was to have cetuximab as well as chemotherapy before and after surgery.

At the end of 2012, the trial team looked at some early results to see how long people in each group were living without any sign of their cancer getting worse. They found this was

  • Just under 15 months in the group having chemotherapy and cetuximab
  • Just under 2 years in the group having chemotherapy alone

In view of these results, the committee monitoring the safety of the trial (data monitoring committee) recommended that the trial was stopped.

The researchers concluded that adding cetuximab to chemotherapy did not help people having surgery to remove bowel cancer that had spread to the liver.

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) 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 John Primrose

Supported by

Cancer Research UK
National Institute for Health Research Cancer Research Network (NCRN)
University Hospital Southampton NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/06/031.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 801

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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