"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at standard treatment with or without irinotecan for cancer of the rectum (ARISTOTLE)
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at adding irinotecan to the standard treatment for rectal cancer. It is for people who have cancer that started in the
More about this trial
As well as killing cancer cells, some chemotherapy drugs can make cancer cells more sensitive to radiotherapy. Having chemotherapy with radiotherapy is often better at shrinking cancer than radiotherapy alone.
In this trial, researchers are looking at adding another chemotherapy drug called irinotecan. They want to find out
- If adding irinotecan to standard treatment stops or helps to delay the cancer coming back following surgery
- More about the side effects
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)
- Are well enough to have treatment
- 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 radiotherapy including internal radiotherapy (brachytherapy)
- Have cancer that has spread to another part of your body (
- 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 systemwhich affects how you absorb tablets
- Have frequent diarrhoea that is difficult to control with medication, your doctor can advise you about this
- Are taking St John’s Wort
- Are not able to have surgery
- Are pregnant or breastfeeding
This is a randomised trial. It will recruit about 600 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 samples of tissue taken when you had the
You will see the doctors and have some tests before you start treatment. The tests may include
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 at 4 weeks then at 1, 2 and 3 years after finishing your chemoradiotherapy.
You see the research team at the hospital at 1 month, 4 months, 6 months, 1, 2, 3, 4 and 5 years after finishing chemoradiotherapy.
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
- Feeling or being sick
- Sore mouth
- Tiredness (fatigue)
The most common side effects of radiotherapy are
How to join a clinical trial
Professor David Sebag-Montefiore
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUK/08/032.