A trial looking at chemotherapy after surgery for pancreatic cancer (ESPAC 3, v2)

This trial is comparing 5-fluorouracil (5FU) chemotherapy with gemcitabine chemotherapy, to see which works best to help prevent pancreatic cancer returning after surgery.

Pancreatic cancer can sometimes be treated with surgery. If the growth in your pancreas has been removed with surgery, there is a chance that your cancer could come back. There is a possibility that giving chemotherapy after surgery, may prevent this happening. This is called adjuvant therapy. Nobody is sure if this is the case or which are the best chemotherapy drugs to use.

This trial is to find out whether one type of chemotherapy is more effective than another. It is comparing gemcitabine and 5-fluorouracil (5FU) with a vitamin, folinic acid given after surgery.

Please note this trial is no longer recruiting patients.

Recruitment

Start 03/07/2000

End 30/04/2008

Phase

Phase 3

Who can enter

You can enter this trial if you:

Have a confirmed diagnosis of pancreatic cancer (other than ductal adenocarcinoma as that part of the trial has now closed)
Have no evidence that the disease has spread (metastasised)
Are fit enough to start chemotherapy 8 weeks after surgery
Have not had cancer before (except basal cell skin cancer or carcinoma in situ of the cervix)
Have no other serious medical conditions

You will not be able to take part in the trial if you:

Have had previous chemotherapy
Have a type of pancreatic cancer called pancreatic lymphoma
Are under 18 years of age
Are pregnant

Trial design

This is a randomised trial with 3 groups. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 will have chemotherapy with gemcitabine
Group 2 will have chemotherapy with 5FU and folinic acid
Group 3 will have no treatment after surgery

If you have a ductal adenocarcinoma, you will not be able to take part. This part of the trial now has all the patients it needs and has closed.

If you have any other type of pancreatic cancer, you will be randomised into one of the 3 groups.

Hospital visits

If you are in group1 or 2 and are given chemotherapy, you will go to the hospital as an outpatient for chemotherapy. This will be given as injections into your vein.

If you are given gemcitabine, you will have to go to hospital once a week for 3 weeks out of every 4 weeks. If you are given 5FU and folinic acid, you will go to hospital for 5 days in a row every 4 weeks.

Both gemcitabine and 5FU treatments are given 6 times. So the total treatment course will last 24 weeks for groups 1 and 2. After your treatment, you will have follow up appointments every 3 months.

If you are in group 3, you will see the doctors every 3 months.

Side effects

All chemotherapy treatment has general side effects. There is more specific information about 5FU and gemcitabine in the chemotherapy section of CancerHelp UK.