A trial comparing gemcitabine alone with gemcitabine and capecitabine together after surgery to remove cancer of the pancreas (ESPAC-4)

Cancer type:

Pancreatic cancer

Status:

Open

Phase:

Phase 3

This trial is looking at gemcitabine on its own or alongside another drug called capecitabine after surgery for cancer of the pancreas or cancer where the pancreatic duct meets the bile duct. This area is called the ampulla of Vater. Cancer that starts there is called ampullary cancer. The trial is supported by Cancer Research UK.

More about this trial

Cancer of the pancreas is very difficult to treat. If possible, doctors use surgery to remove the cancer. But even if you have the cancer removed, there is a risk that it will come back. Some trials have 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 are looking at adding another drug called capecitabine.

The aims of the trial are

  • to see if gemcitabine combined with capecitabine works better than gemcitabine alone after surgery for pancreatic cancer
  • to learn more about the side effects of treatment

Please note - the trial has finished recruiting people with cancer of the pancreas and is now only recruiting people with cancer that starts in the area called the ampulla of Vater (ampullary cancer).

 

Diagram showing the bile ducts in the pancreas

Who can enter

You can enter this trial if you

  • Have ductal adenocarcinoma of the pancreas or cancer where the pancreatic duct meets the common bile duct (this area is called the ampulla of Vater).
  • Have had surgery to remove the cancer in the last 12 weeks, and your surgeon was able to remove both the cancer and a border of tissue around it
  • Have recovered from your surgery and are well enough to take part in the trial
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use a reliable form of contraception if there is any chance you or your partner could become pregnant

Please note - the trial has finished recruiting people with ductal adenocarcinoma and is now only recruiting people with ampullary cancer.

You cannot enter this trial if you

Trial design

This is an international trial that will recruit 1,412 people all together. It has already recruited 722 people with cancer of the pancreas. It is now only recruiting people who have cancer where the pancreatic duct meets the common bile duct (the area called the ampulla of Vater).

The trial is randomised. You will be put into one of 2 treatment groups by a computer. Neither you nor your doctors will be able to decide which group you are in.

Everybody taking part will have chemotherapy in 28 day (4 week) cycles of treatment. You have up to 6 cycles of treatment, lasting nearly 6 months (24 weeks) in all.

If you are in group 1, you have gemcitabine through a drip into a vein on days 1, 8 and 15 of each treatment cycle.

If you are in group 2, you have gemcitabine in the same way as group 1, and you have capecitabine tablets to take at home on days 1 to 21 of each treatment cycle.

The doctors will ask you to fill in a questionnaire at the beginning of the trial, after 3, 6, 12, 18 and 24 months, and then once a year for up to 5 years. The questionnaire will ask about how you are feeling and any side effects you have. This is called a quality of life study.

The researchers will ask your permission to take a number of blood and urine samples when you go to your hospital appointments. This is so that they can learn more about pancreatic cancer. They will also ask your permission to take samples of both normal tissue and cancer cells during your surgery. And to collect more blood and urine samples on the day of the operation.

All samples will be stored safely and may be used in the future, but only for research purposes. If you do not want to give these extra samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

Before you start treatment, you will go to the hospital to see the doctors and have some tests. These include

  • Physical examination
  • CT scan
  • Heart trace (ECG)
  • Blood tests

You will go to hospital 3 times in each cycle of treatment to have gemcitabine. You have this in the outpatient department and it takes about 2 hours each time. You will have regular blood tests during your course of treatment.

After you finish your treatment, you will see the doctors every 3 months for up to 5 years. You will have a blood test at each visit.

Side effects

The most common side effects of gemcitabine and capecitabine include

We have more information about the side effects of gemcitabine and capecitabine in our cancer drugs section.

Location

Ashford
Ashington
Bangor
Barnstaple
Basingstoke
Bedford
Belfast
Birmingham
Bishop Auckland
Blackburn
Blackpool
Bournemouth
Bradford
Bristol
Burton on Trent
Bury St Edmunds
Cambridge
Canterbury
Cardiff
Carlisle
Cheltenham
Colchester
Cottingham
Coventry
Crewe
Darlington
Dartford
Derby
Durham
Eastbourne
Edinburgh
Exeter
Glasgow
Gloucester
Great Yarmouth
Grimsby
Guildford
Hastings
Hereford
Huddersfield
Huntingdon
Inverness
Ipswich
Lancaster
Leeds
Leicester
Liverpool
London
Maidstone
Manchester
Margate
Middlesbrough
Newcastle upon Tyne
Newport
North Shields
Norwich
Nottingham
Oxford
Peterborough
Plymouth
Poole
Portsmouth
Preston
Redditch
Rhyl
Romford
Salisbury
Sheffield
Shrewsbury
Southampton
Southend on Sea
Stafford
Stoke-on-Trent
Swansea
Swindon
Torquay
Winchester
Wirral
Worcester
Wrexham
Yeovil

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 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

Other information

This is Cancer Research UK trial number CRUK/07/024.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

636

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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