
"I am glad that taking part in a trial might help others on their own cancer journey.”
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.
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:
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:
They were put into a treatment group at random:
The research team looked at how many people were living after 6 months, they found it was:
And the number of people living at 12 months was:
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:
The most common of the more severe side effects were:
Three people who had FOLFOX died because of side effects of treatment:
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 () 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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Juan Valle
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
This is Cancer Research UK trial number CRUK/13/004.
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”