
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at giving the drug cetuximab as well as chemoradiation before surgery for cancer of the back passage (rectal cancer).
We know from research that cancer of the back passage (rectum) can be successfully treated with radiotherapy and chemotherapy before surgery. This combination of treatment works well for many people, but for some, the cancer comes back after a time.
A drug called cetuximab may help reduce the risk of the cancer coming back. Cetuximab is a type of biological therapy called a monoclonal antibody. Monoclonal antibodies can seek out cancer cells by looking for particular proteins on the cell’s surface.
People taking part in this study will have capecitabine chemotherapy with their radiotherapy, with or without cetuximab. The main aim of this study is to see if people do better with cetuximab, and which treatment plan works best. Researchers also hope to learn more about the safety and side effects of the combination of cetuximab, capecitabine and radiotherapy.
You can enter this study if
You cannot enter this study if
This study is in 2 parts. Part 1 was completed a while ago. Part 2 is randomised. 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.
If you are in group 1, you have cetuximab through a drip into vein, once a week for 4 weeks. You then have radiotherapy and capecitabine chemotherapy (chemoradiation) every weekday for 5 weeks. After this, you have cetuximab once a week, for 5 more weeks.
If you are in group 2 you will just have the chemoradiation.
After you finish treatment, you have your surgery as planned, which is not part of the study.
The team will also ask for permission to study the tissue removed for your diagnosis (biopsy). If you are having cetuximab in the study, the team would also like to take 2 fresh tissue samples during your first course of cetuximab. And a sample of tissue from your surgery.
Everyone will also give a number of blood samples.
Before you start the study you will see the doctor and have some tests. These tests include
Everyone will come to hospital every weekday for 5 weeks for chemoradiation.
If you are having cetuximab in group 1, you will also come to the hospital once a week for 4 weeks before chemoradiation. And then once a week for 5 weeks after chemoradiation.
After your study treatment and before your surgery, you will have another MRI scan.
If you are having cetuximab, you will have an extra biopsy under
You will give a study blood sample whenever you have a biopsy, and also
Everyone taking part in the main study will see the study team for a check up at
Side effects of capecitabine include
Capecitabine may affect, or be affected by, other medication. If you take phenytoin, drugs to thin your blood, vitamin B6 (pyridoxine) or antiviral treatment you must tell your study doctor.
Side effects of cetuximab include
Side effects of rectal radiotherapy include
You can find out more about the side effects of capecitabine, cetuximab and rectal radiotherapy on CancerHelp UK.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr R Glynne-Jones
Experimental Cancer Medicine Centre (ECMC)
Merck Pharmaceuticals
NIHR Clinical Research Network: Cancer
University College London (UCL)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”