
"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 trial is looking at radiotherapy and the drug nimorazole for people with head and neck cancer. The trial is for people with cancer that may have spread to or into surrounding body tissues (locally advanced cancer), but has not spread to another part of your body. The trial is supported by Cancer Research UK.
Doctors often use radiotherapy to treat people with head and neck cancer.
Most cancers have some cells with a low level of oxygen. These are more difficult to kill with radiotherapy than cancer cells with a normal oxygen level. Nimorazole is a drug that gets into the cells with a low level of oxygen. These cells are then more likely to be killed by radiotherapy.
In this trial, doctors will compare nimorazole with a dummy drug ().
The aims of the trial are to find out
You may be able to join this trial if all of the following apply
You cannot join this trial if any of these apply. You
This trial will recruit 340 patients in the UK. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
You have radiotherapy once a day, Monday to Friday, for 6 weeks. You take a tablet (either the dummy drug or nimorazole) every day that you have treatment. If you are unable to swallow the tablets, they can be crushed or taken through a feeding tube.
The trial team will ask you to fill in a questionnaire
The questionnaire will ask about any side effects you have and how you are feeling. This is called a quality of life questionnaire.
The researchers will get a piece of tissue from the sample of tissue removed when you had a to diagnose your cancer. These samples will be stored safely and only used for research purposes. You must agree to this to take part in the trial.
They will also take some extra blood samples each year. You don't have to agree to these blood samples. You can still take part in the trial.
Studying these samples may help researchers learn more about which people would benefit from having nimorazole and why some people have worse side effects from radiotherapy than others.
The trial team will also give you a diary and ask you to write down:
You will see the doctor and have some tests before you start treatment. These tests may include
You see the doctor every week during treatment. During the 4th week of the treatment, you have a blood test.
When you finish treatment, you see the doctor 6 weeks and 3 months later. After that you see them every 6 months for 2 years and then once a year for another 3 years.
3 months after completing treatment you will also have a:
All treatments have side effects. The side effects of radiotherapy to the head and neck include
The possible side effects of nimorazole include
As with any new treatment, it is possible that there could be some side effects the doctors don’t know about yet.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr David Thomson
Azanta
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Christie NHS Foundation Trust
This Cancer Research UK trial number CRUK/13/006.
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”