A trial looking at chemotherapy after surgery to remove cancer of the pancreas (ESPAC-4)

Cancer type:

Pancreatic cancer

Status:

Results

Phase:

Phase 3

This trial compared gemcitabine on its own with gemcitabine alongside capecitabine after surgery for cancer of the pancreas.

There are 2 parts to this trial. Part 1 was for people with the most common type of pancreatic cancer. This is called ductal adenocarcinoma cancer of the pancreas. This part of the trial is now closed and the trial team published these results in 2017. The results are summarised in the trial result section below.

Part 2 is closed to recruitment. It is looking at people with cancer where the pancreatic duct Open a glossary item meets the bile duct Open a glossary item, the ampulla of Vater. This is called ampullary cancer. We have a summary of this on our trials database.

Cancer Research UK supports this trial.

More about this trial

Cancer of the pancreas is very difficult to treat. If possible, the usual treatment is surgery to remove the cancer. But there is a risk that it will come back.

When this trial was done, some trials had shown that having chemotherapy after surgery helps to stop or delay the cancer coming back.

Gemcitabine is a chemotherapy drug doctors often use to treat cancer of the pancreas. In this trial, the researchers looked at adding another chemotherapy drug called capecitabine.

The aims of the trial were to:

  • find out if gemcitabine and capecitabine worked better than gemcitabine after surgery for pancreatic cancer
  • learn more about the side effects 

Summary of results

The trial team found having gemcitabine and capecitabine works as a treatment for cancer of the pancreas. And the side effects were manageable.

730 people took part. They had surgery to remove the cancer of the pancreas and the border around it. Within 12 weeks of their surgery:

  • 366 had gemcitabine
  • 364 had gemcitabine and capecitabine

The researchers looked at how long people lived for after treatment. This is called overall survival. They found on average this was:

  • 25.5 months in people who had gemcitabine
  • 28 months in people who had gemcitabine and capecitabine

ESPAC-4 Trial Diagram

They also looked at side effects. As expected, people having gemcitabine and capecitabine had more side effects overall. The more serious ones were:

  • diarrhoea
  • numbness, tingling, redness or soreness on the palms of the hands or soles of the feet. This is called hand foot syndrome
  • a drop in the number of a type of white blood cell called neutrophils Open a glossary item. This is called neutropenia

But overall, the number of people who had neutropenia and a raised temperature (fever) was low in both treatment groups.

The trial team concluded that the people having gemcitabine and capecitabine lived longer after surgery for cancer of the pancreas. They recommend it is the new standard treatment for people having chemotherapy after surgery for ductal adenocarcinoma cancer of the pancreas.

The researchers who ran the trial say, having gemcitabine and capecitabine after surgery is being widely adopted as the standard of treatment around the world.

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

Prof John Neoptolemos

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Royal Liverpool and Broadgreen University Hospital NHS Trust
University of Liverpool

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14612

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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