A trial of chemotherapy followed by chemoradiotherapy for locally advanced pancreatic cancer (SCALOP)

Who can enter

You can enter this trial if you

• Have pancreatic cancer that is locally advanced
• Have cancer that cannot be removed with surgery, or you are not fit enough to have an operation
• Are well enough to take part in the trial (performance status 0, 1 or 2)
• Have satisfactory blood test results
• Are willing to use reliable contraception during the trial and for 3 months after if there is any chance you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have cancer that has spread to another part of your body
• Have a neuroendocrine tumour or lymphoma of the pancreas
• Have cancer that has come back after surgery to try to cure it
• Have a tumour in your pancreas that is bigger than 7cm across
• Have already had radiotherapy to the top of your abdomen
• Have had any other cancer in the last 5 years, apart from basal cell skin cancer that has been successfully treated, carcinoma in situ of the cervix or another early stage cancer
• Have kidney problems
• Have had a heart attack or a stroke in the last 6 months
• Have another serious medical condition that cannot be controlled with medication
• Are pregnant or breastfeeding

Trial design

This trial will recruit about 100 people at hospitals throughout the country. Everybody taking part will have 12 weeks of chemotherapy called GemCap. You have this in 4 week cycles of treatment. You have gemcitabine through a drip into a vein once a week for 3 weeks. This takes about half an hour each time. And you take capecitabine tablets twice a day for 3 weeks. Then you have a week without any treatment before you start the next cycle.

After 3 cycles of GemCap you have a CT scan. If the scan shows that the cancer has got bigger or you are not well enough to have chemoradiotherapy, your doctor will talk to you about other treatment options.

If the scan shows that the cancer has stayed the same size or got smaller, and you are well enough to have more treatment, you will be put into one of 2 groups by a computer. This is called randomisation. Neither you nor your doctor will be able to decide which group you are in.

You carry on having GemCap chemotherapy for another 4 weeks and your doctors plan your radiotherapy. Then you start having chemoradiotherapy.

You have radiotherapy every day (Monday to Friday) for 5 and a half weeks.

• If you are in group 1, you have gemcitabine through an injection into a vein once a week
• If you are in group 2, you have capecitabine as tablets twice a day for 5 days each week

You will be asked to fill in a questionnaire

• Before you start treatment
• At the end of the GemCap chemotherapy
• After the chemoradiotherapy
• 3 more times during the next year

The questionnaire will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.

The trial team will also ask if they can take 4 extra blood samples during the trial. The researchers will look at the DNA in your blood to learn more about your genes and whether they affect how you respond to treatment. If you don’t want to give these blood samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

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

• Physical examination
• Blood tests
• CT scan

Everybody taking part in the trial will go to hospital at least 9 times to have GemCap chemotherapy. If you continue in the trial after that, you will have 3 more hospital visits for one further cycle of GemCap. Then you will go to hospital every day for at least 5 and a half weeks during your chemoradiotherapy.

After you finish treatment, you will have blood tests and a CT scan every 3 months for a year. You will see the trial doctors at least once every 3 months in the first year, but they may want to see you more often. Your doctor will talk to you about how often you need follow up appointments in the following year.

Side effects

The side effects of radiotherapy for pancreatic cancer include sickness, diarrhoea, tiredness and sore skin in the area where you have treatment.

The side effects of the chemotherapy drugs in this trial include

• Tiredness (fatigue)
• A drop in the number of blood cells causing an increased risk of infection, tiredness, shortness of breath, bruising or bleeding problems
• Sickness
• Sore mouth

There is more information about the side effects of gemcitabine, capecitabine and GemCap on CancerHelp UK