A trial of chemotherapy and radioembolisation for bowel cancer that has spread to the liver (FOXFIRE)

Cancer type:

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

Status:

Results

Phase:

Phase 3

This trial was for people with bowel cancer that had spread to their liver. Their cancer in the liver could not be completely removed with surgery, or cured with other treatments. This trial was supported by the Bobby Moore Fund of Cancer Research UK.

More about this trial

One area that bowel cancer might spread to is the liver. This spread is called liver secondaries or liver metastases. Sometimes it’s possible to remove these liver secondaries with surgery. Or chemotherapy might help to shrink or control the cancer if surgery is not possible.
 
Doctors are looking for new treatments that will control the growth of liver secondaries. This trial looked at a treatment called radioembolisation Open a glossary item. Radioembolisation uses very small radioactive beads called microspheres.
 
To have radioembolisation, your doctor makes a small cut in your groin. They pass a fine tube (catheter) through the cut up into blood vessels in the liver. You then have the microspheres injected through the catheter. These travel to the small blood vessels in and around the cancer. The beads give off radiotherapy Open a glossary item.
 
The radiotherapy damages the cancer cells and the cancer’s blood supply. The microspheres only give off radiation to a small area. So they cause little damage to the surrounding healthy tissue. This treatment is also called Selective Internal Radiation Therapy (SIRT).
 
The aims of the trial were to:
  • find out if radioembolisation and chemotherapy works better than chemotherapy alone for bowel cancer that has spread to the liver
  • learn more about the side effects of radioembolisation when combined with chemotherapy

Summary of results

The trial team found that having the combination of radioembolisation and chemotherapy did not improve how long people lived for after treatment for people with liver secondaries.
 
Trial design 
This was a phase 3 trial and it was randomised. The people taking part were put into 1 of 2 treatment groups by a computer. Neither they nor your doctor could decide which group they were in.
  • People in one group had chemotherapy alone.
  • People in the other group had chemotherapy combined with radioembolisation.
Everybody taking part had the chemotherapy drugs oxaliplatin and 5FU (fluorouracil), along with a vitamin called folinic acid. People had a chemotherapy regime called OxMdG or FOLFOX. The dose and timing of the drugs is slightly different with each regime but they contain the same drugs. Each cycle of treatment was over 2 weeks. On average, most people in the trial had 12 cycles of treatment.
 
People in group B had radioembolisation once during their 2nd cycle of chemotherapy.
 
Combined results of 3 trials 
The results of this trial were looked at and combined with the results of 2 other trials. These were the:
  • SIRFLOX trial
  • FOXFIRE-Global trial
These trials recruited people from other countries in Europe as well as Australia, New Zealand, Asia, the Middle East and USA. Both these trials recruited a similar group of people with liver metastases. People had slightly different chemotherapy regimes, but with the same chemotherapy drugs. Around half of the people in these trials had radioembolization in combination with chemotherapy.
 
Across the 3 trials:
  • 549 people had chemotherapy alone
  • 554 people had chemotherapy plus radioembolisation
At the time the results were published, all 3 trials had completed at least 2 years of follow up of their patients.
 
Overall survival
The researchers looked at how long people lived for after treatment (overall survival). They found that on average, this was:
  • about 23 months in the chemotherapy group
  • about 23 months in the chemotherapy plus radioembolisation group
So the team concluded that adding radioembolisation to chemotherapy did not improve the overall survival for these people compared to chemotherapy alone.
 
The trial team also recorded who had died from any cause. This was:
  • 411 people (75%) had died in the chemotherapy group 
  • 433 people (78%) had died in the chemotherapy plus radioembolisation group
The trial team concluded the difference between these groups was not significant.
 
Control of liver secondaries
The trial team specifically looked at the liver secondaries of those taking part. They did this by looking at people’s scans They recorded whether the liver secondaries:
  • reduced in size 
  • could no longer be found on scans 
These are called an objective response. Out of the 1103 people, an objective response was found in:
  • 346 people (63%) in the chemotherapy group
  • 400 people (72%) in the chemotherapy plus radioembolisation group
Significantly more people in the radioembolisation group had a response on scans. But this did not lead to an improved survival in this group of people. The researchers think this is because people in this group had less chemotherapy after the trial, compared to the group who only had chemotherapy.
 
Side effects and quality of life
Those people who had radioembolisation had more side effects following this treatment. These included:
  • a drop in the number of white blood cells called neutrophils, leading to infection 
  • tummy (abdominal) pain 
  • feeling sick or being sick
Those people who had radioembolisation had less numbness in their fingers and toes.
 
Everybody taking part filled out a questionnaire about quality of life at different points during and after their treatment. The trial team concluded that people in both treatment groups had a similar quality of life.
 
The researchers do not recommend radioembolisation as an initial treatment in combination with chemotherapy for bowel cancer that has spread to the liver.
 
They believe that further trials should look at radioembolisation in selected groups of people with bowel cancer and liver secondaries. For example, as a possible treatment after chemotherapy has stopped working. Or as a treatment in patients who do not do as well with standard chemotherapy treatments.
 
We have based this summary on information from the research team. 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 who did the research. 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 Ricky Sharma
Dr Harpeet Wasan

Supported by

Bobby Moore Fund (BMF)
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sirtex
University of Oxford

Other information

This is Cancer Research UK trial number CRUK/07/030.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

1722

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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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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