A trial looking at chemotherapy for advanced cancer of the bile duct or gallbladder (ABC 02)

Cancer type:

Bile duct cancer
Biliary tree cancers
Gallbladder cancer

Status:

Results

Phase:

Phase 3

This trial was looking at gemcitabine, with or without cisplatin, for people with advanced cancer of the bile duct or gallbladder. This trial was supported by Cancer Research UK.

 

More about this trial

Cancer of the bile duct or cancer of the gallbladder is often diagnosed when it is advanced, when surgery is not possible.

Doctors thought chemotherapy may be useful for treating advanced cancer of the bile duct or gallbladder that could not be removed with surgery. But they were not sure which chemotherapy drugs were the best to use.

This trial compared gemcitabine on its own with gemcitabine and cisplatin together. The aims of this trial were to find out which treatment

  • Helped people to live longer
  • Was better at controlling the cancer
  • Caused fewer side effects

Summary of results

The researchers found that the combination of gemcitabine and cisplatin worked better than gemcitabine alone. And it didn’t cause any more side effects.

The trial recruited 410 people. Half the people had gemcitabine alone, half had gemcitabine and cisplatin.

Just over half the people taking part became more unwell during treatment. Some of this was due to the chemotherapy. This was the same for both groups. A few more people in the group having both drugs had a drop in the number of blood cells.

The average length of time before the cancer started growing again was

  • 8 and a half months for people having both drugs
  • 6 and a half months for people having gemcitabine alone

And the average length of time that people lived after they were put into the trial was also longer in the group having both drugs (11 months) than in the group having gemcitabine alone (8 months).

As the results showed that the combination of both drugs worked better, the researchers suggest this should become standard treatment Open a glossary item for advanced cancer of the bile duct or gallbladder.

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 Open a glossary item) 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

Dr John Bridgewater
Dr Harpreet Wasan
Dr Juan Valle

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUK/04/012.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 420

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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