
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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 and has spread into the surrounding tissues (
). This trial is supported by Cancer Research UK.
Doctors usually treat locally advanced rectal cancer with chemotherapy and radiotherapy followed by surgery. Having both treatments together is called chemoradiotherapy.
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.
The chemotherapy drug capecitabine with radiotherapy is to shrink rectal cancer before having surgery to remove it.
In this trial, researchers are looking at adding another chemotherapy drug called irinotecan. They want to find out
You may be able to enter this trial if you
You cannot enter this trial if you
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
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 to diagnose your cancer and after surgery, if you have surgery. 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.
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
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
The most common side effects of radiotherapy are
We have more information about irinotecan, capecitabine and the side effects of radiotherapy.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
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.
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.