A trial looking at capecitabine after surgery for cancer of the bile duct or gallbladder (BILCAP)

Who can enter

You can enter this trial if you

• Have been diagnosed cancer of the bile duct or gallbladder
• Have had surgery to completely remove the cancer
• Have satisfactory blood test results
• Are well enough for chemotherapy (performance status 0, 1 or 2)
• Are at least 18 years old
• Are prepared to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

• Have cancer of the pancreas (pancreatic cancer) or cancer only in the lining of the gall bladder (mucosal gall bladder cancer)
• Have a blockage (obstruction) anywhere in your gall bladder system
• Have had any other cancer in the last 5 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
• Have any other serious medical condition
• Have had chemotherapy or radiotherapy for biliary tract cancer
• Have had an experimental treatment as part of a clinical trial in the last 4 weeks
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 360 patients into 2 groups. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group A you will have capecitabine after your operation. You will take capecitabine tablets twice a day for 2 weeks out of every 3. Each 3 weeks of treatment is one cycle. You will have 8 cycles over nearly 6 months (24 weeks).

If you are in group B you will not have any chemotherapy as part of this trial.

Everyone taking part will fill in a questionnaire before starting treatment, and then every 3 months for a year and every 6 months for another year. It will ask you how you have been feeling and about any side effects you have had. This is called a quality of life questionnaire.

If you agree to take part in this trial, the researchers will ask for a sample of tissue taken when you have surgery to remove your cancer, and a blood sample. These samples will be stored and used in the future to help researchers find out more about biliary tract cancer. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you join the trial. The tests include

• Physical examination
• Blood tests
• CT scan

If you are in group A you will have blood tests before each cycle of treatment (every 3 weeks).

Everyone taking part will see the doctors every 3 months for a year, then every 6 months for a year, and once a year for 3 years after that. You will have blood tests and a physical examination at each visit. You will have a CT scan every 6 months for 2 years and then once a year for another 3 years.

If there are signs that your cancer has come back, your doctor will discuss the treatment options with you. You may be able to have chemotherapy, for example.

Side effects

The most common side effects are

• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
• Diarrhoea
• Mouth ulcers
• Feeling or being sick
• Redness and soreness of hands and feet (palmar-plantar syndrome)

There is more information about capecitabine (Xeloda) on CancerHelp UK.