A trial looking at standard treatment with or without irinotecan for cancer of the rectum (ARISTOTLE)

Who can enter

You may be able to enter this trial if you

• Have rectal cancer that has spread into surrounding tissues (locally advanced rectal cancer)
• Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• Have satisfactory blood test results
• Are willing to use reliable contraception during the trial and for 3 months after if there is any chance that you or your partner could become pregnant
• Are aged 18 years old or more

You cannot enter this trial if you

• Have already had chemotherapy
• Have already had radiotherapy including internal radiotherapy (brachytherapy)
• Have cancer that has spread to another part of your body (metastatic cancer)
• 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
• Are taking certain types of medication including warfarin, your doctor can advise you about this
• Have any problems with your digestive system which affects how you absorb tablets
• Are taking St John’s Wort
• Are not able to have surgery
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit about 920 people in the UK.

The people taking part are put into 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in groups A and B

• Take capecitabine tablets 5 days a week, from Monday to Friday, for 5 weeks
• Have radiotherapy every day from Monday to Friday for 5 weeks (at the same time as taking capecitabine)

People in group B also have irinotecan. You have it through a drip into a vein once a week for 4 weeks. It takes about an hour each time.

People in both groups have surgery 8 to 10 weeks after completing chemoradiotherapy. Some people may have more chemotherapy after surgery, your doctor will discuss this with you.

You fill out a questionnaire before you start treatment and then 1, 2 and 3 years after finishing your chemoradiotherapy. The questionnaire will ask about side effects and how you have been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for blood samples and to use the sample of tissue taken when you had the biopsy  to diagnose your cancer. You will not have to have an extra biopsy. These will be used for future research in rectal cancer. If you do not want to give the 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 start treatment. The tests may include

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

You will have blood tests and a physical examination

• Every week during chemoradiotherapy
• At the end of chemoradiotherapy
• 4 weeks after finishing chemoradiotherapy

You have to go to the hospital for radiotherapy as an outpatient daily from Monday to Friday for 5 weeks. In group 2, you also have irinotecan at the hospital once a week for 4 weeks. This takes an hour.

You have a CT scan 1, 2 and 3 years after finishing your chemoradiotherapy.

You see the research team at the hospital, 3 months, 6 months, 1, 2, 3, 4 and 5 years after finishing chemoradiotherapy.

Side effects

The most common side effects of irinotecan and capecitabine are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Diarrhoea
• Feeling or being sick
• Sore mouth
• Tiredness (fatigue)

The most common side effects of radiotherapy are

• Sore skin
• Diarrhoea
• Wanting to pass urine more often (urinary frequency)

There is more information about irinotecan, capecitabine and radiotherapy on CancerHelp UK.