A trial looking at capecitabine after surgery for cancer of the bile duct or gallbladder (BILCAP)

Cancer type:

Bile duct cancer

Biliary tree cancers

Gallbladder cancer

Status:

Results

Phase:

Phase 3

This trial compared surgery and capecitabine with surgery alone for cancer of the bile duct or gallbladder (also called biliary tract cancer).

Cancer Research UK supported this trial.

This trial was open for people to join between March 2006 and December 2014. The results were published in 2019.

More about this trial

For biliary tract cancer diagnosed at an early stage, the best treatment is an operation to remove it. But sometimes the cancer starts to grow again after surgery.

Chemotherapy after surgery (adjuvant chemotherapy) can help stop some types of cancer from coming back.

Doctors thought a chemotherapy drug called capecitabine (Xeloda) might stop biliary tract cancer coming back after surgery. But they weren’t sure.

Capecitabine does have side effects, and it is important that people don’t have treatments they don’t need.

In this trial half the people had capecitabine after their surgery. And the other half didn’t have capecitabine.

The aim of this trial was to find out if capecitabine stopped cancer of the gall bladder or bile duct coming back after surgery.

Summary of results

The trial team found that taking capecitabine after surgery might lengthen the time people live.

About this trial

This was a phase 3 trial.

It was a randomised trial. Everyone who took part was put into 1 of 2 groups. Neither they nor their doctor chose which group they were in.

447 people joined the trial. After their surgery:

223 people had capecitabine
224 people didn’t have capecitabine

481-randomisation.png

Results

The average follow up was 5 years. The team looked at the overall average length of time people lived after surgery. They found it was:

over 4 years (51.1 months) for those who had capecitabine
over 3 years (36.4 months) for those who didn’t have capecitabine

481-graph-1.png

They also looked at the average length of time people were free of their cancer after surgery. They found it was:

just over 2 years (24.4 months) for those who had capecitabine
just under 1½ years (17.5 months) for those who didn’t have capecitabine

481-graph-2.png

Long term follow up

The team compared the people who were to have treatment (intended to treat Open a glossary item

) and those who actually had treatment. Looking at everyone who was randomised makes the results more accurate. This is so even if for some reason they didn’t have treatment.

Between years 2 and 5 after treatment they found that there was not much difference in how many people in each group were alive and had no sign of cancer.

The researchers think it is because capecitabine might have delayed their cancer coming back. To understand this further the team is continuing to follow these people up.

They will look at how many people are alive 5 years after their surgery. And will continue to follow everyone up for longer because it looks like capecitabine might delay the cancer coming back rather than stop it coming back.

When these results are available we will update this summary.

Side effects

In the capecitabine group 94 people (44%) reported having at least 1 severe side effect. The most commonly reported severe side effects were:

hand and foot syndrome
diarrhoea
tiredness

Conclusion

The team concluded these results suggest that taking capecitabine after surgery to remove biliary tract cancer could improve the length of time people lived. So capecitabine after surgery should be considered as standard treatment Open a glossary item

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:

16/03/2006

Recruitment end:

31/12/2014

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.

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Chief Investigator

Professor John Primrose

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Southampton
Cancer Research UK Clinical Trials Unit, University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/05/002.

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

Freephone 0808 800 4040

Email

Last review date

6 August 2019

CRUK internal database number:

481