Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial comparing gemcitabine alone with gemcitabine and capecitabine together after surgery to remove cancer of the pancreas (ESPAC-4)
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).
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
- Have stage 4 pancreatic cancer
- Have cancer that your surgeon was not able to remove completely
- Have pancreatic lymphoma
- Have already had chemotherapy
- Have had any other cancer, apart from basal cell skin cancer or carcinoma in situ of the cervix that have been successfully treated
- Have any other serious medical condition
- Are pregnant
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.
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 (
- 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.
The most common side effects of gemcitabine and capecitabine include
- A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
- Sore mouth
- Feeling or being sick
- Sore hands and feet
- Flu like symptoms
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.
Professor John Neoptolemos
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Royal Liverpool and Broadgreen University Hospital NHS Trust
University of Liverpool
This is Cancer Research UK trial number CRUK/07/024.