A trial looking at oxaliplatin and 5FU for advanced biliary tract cancers (ABC-06)

Cancer type:

Bile duct cancer
Biliary tree cancers
Gallbladder cancer

Status:

Results

Phase:

Phase 3

This trial was done to find out if oxaliplatin and 5FU is useful for people with advanced biliary tract cancer who have already had chemotherapy. 

The trial was supported by Cancer Research UK. It was open for people to join between 2014 and 2017. The team published the results in 2021.

More about this trial

Biliary tract cancers include cancer of the:

Doctors often treat biliary tract cancer that has spread with chemotherapy, such as gemcitabine and cisplatin. But the cancer can start to grow again. 

When this trial was done, doctors would treat the symptoms of cancer for people in this situation. This is called active symptom control, or ASC. It includes treatment such as painkillers, antibiotics or steroids. But there was no standard chemotherapy treatment.

Researchers wanted to find out if oxaliplatin and fluorouracil (5FU) could be helpful for people in this situation. You have these drugs with another drug called folinic acid, which helps 5FU work better. This combination is known as FOLFOX.

The main aims of the trial were to find out:

  • if FOLFOX could help people with advanced biliary tract cancer
  • more about the side effects of FOLFOX for people in this situation

Summary of results

The research team found that FOLFOX may be a useful treatment for people with biliary tract cancer that has got worse after previous chemotherapy.

Trial design
This trial was for people who had already had chemotherapy. But their cancer continued to grow, either straight after treatment or a little while later.  

The people taking part were put into a treatment group at random. Some people had active symptom control as usual. And some had FOLFOX chemotherapy as well as active symptom control.

Results
A total of 162 people joined this trial. There were:

  • 117 people with bile duct cancer
  • 34 people with gall bladder cancer 
  • 11 people with ampullary cancer

They were put into a treatment group at random:

  • 81 had active symptom control (ASC)
  • 81 had active symptom control and FOLFOX chemotherapy

The research team looked at how many people were living after 6 months, they found it was:

  • more than 3 out of 10 people (36%) who had ASC
  • just over 5 out of 10 people (51%) who had ASC and FOLFOX

And the number of people living at 12 months was:

  • just over 1 out of 10 people (11%) who had ASC
  • more than 2 out of 10 people (26%) who had ASC and FOLFOX

Side effects
Many people who took part had at least 1 side effect from treatment. Some were mild or didn’t last long. But some people in each group had more severe side effects:

  • 42 people (52%) who had ASC 
  • 56 people (69%) who had ASC and FOLFOX

The most common of the more severe side effects were:

  • a drop in white blood cells
  • extreme tiredness (fatigue)
  • infection

Three people who had FOLFOX died because of side effects of treatment:

  • one person had sudden and serious kidney damage (acute kidney injury)
  • one person had an infection
  • one person had a drop in white blood cells and a temperature (febrile neutropenia)

We have more information about the side effects of FOLFOX chemotherapy in our cancer drugs section.

Conclusion
The trial team concluded that FOLFOX is a useful treatment for people with advanced biliary tract cancer. 

They suggest this combination should be standard treatment for people whose cancer has come back after chemotherapy. They now have information on the pros and cons of FOLFOX, so patients can discuss whether they would like this treatment or not.

Where this information comes from    
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 Juan Valle

Supported by

AMMF – The Cholangiocarcinoma Charity
Cancer Research UK
Conquer Cancer Foundation
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Stand Up To Cancer
The Cholangiocarcinoma Foundation
The Christie Charity
The Christie NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/13/004.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10895

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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