A trial looking at nimorazole and radiotherapy for head and neck cancer (NIMRAD)

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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer

Status:

Closed

Phase:

Phase 3

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 lymph nodes Open a glossary item 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 (placebo Open a glossary item).

The aims of the trial are to find out

  • Whether giving nimorazole with radiotherapy is a better treatment than radiotherapy alone
  • The side effects of nimorazole

Who can enter

You may be able to join this trial if all of the following apply

  • You have a head and neck cancer that started in cells called squamous cells Open a glossary item
  • Your cancer may have spread to lymph nodes Open a glossary item or surrounding body tissues (locally advanced cancer), but has not spread to another part of your body
  • You are able to have radiotherapy
  • You have satisfactory blood test results
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You can’t have chemotherapy using a platinum  drug Open a glossary item such as cisplatin or drugs called monoclonal antibodies
  • You are willing to use reliable contraception during treatment and for 1 week after you have finished treatment if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have cancer in your nose (nasal cavity or paranasal sinuses), mouth (oral cavity), or nasopharynx
  • Have had chemotherapy in the last 6 months
  • Have had radiotherapy to your head and neck before
  • Have had surgery to remove your cancer with the aim to cure it
  • Have certain heart or lung conditions (your doctor can advise you about this)
  • Have a low level of red blood cells (anaemia Open a glossary item) in the week before treatment is due to start (you may be able to have a blood transfusion Open a glossary item to top up your red blood cells)
  • Have been diagnosed with numbness or tingling particularly in your hands and feet (peripheral neuropathy Open a glossary item)
  • Have had an experimental drug in the last month
  • Have a medical condition affecting your bowel such as Crohn’s disease or ulcerative colitis, or have had surgery to your bowel or stomach that affects your ability to absorb drugs and nutrients
  • Have had another cancer in th past 5 years apart fron basal cell skin cancer Open a glossary item or an early cancer called carcinoma in situ Open a glossary item
  • Have any other medical condition that could affect your taking (your doctor can advise you about this)
  • Have to take drugs called lithium or phenobarbitone
  • Are breastfeeding or pregnant

Trial design

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.

  • People in one group have radiotherapy and a dummy drug (placebo Open a glossary item)
  • People in the other group have radiotherapy and nimorazole

NIMRAD trial diagram

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

  • Before treatment
  • 6 weeks later (or sooner if you finish the treatment early)
  • Then at 6, 12, 18, 24 and 36 months after treatment has finished

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 biopsy Open a glossary item 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:

  • The time you take your tablets
  • How many tablets you took
  • The time you started radiotherapy

Hospital visits

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:

  • CT scan or MRI scan of your head and neck 
  • CT scan of your chest

Side effects

All treatments have side effects. The side effects of radiotherapy to the head and neck include

  • A sore or dry mouth
  • Mouth ulcers
  • Fungal infection of the mouth (thrush)
  • Taste changes
  • Difficulty swallowing
  • Weight loss
  • Voice changes (your voice may become hoarse or husky)
  • Hair loss in the treated area

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.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr David Thomson

Supported by

Azanta
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Christie NHS Foundation Trust

Other information

This Cancer Research UK trial number CRUK/13/006.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10876

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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