A study comparing 2 ways of having radiotherapy with chemotherapy for head and neck cancer (ARTFORCE)

Cancer type:

Head and neck cancers
Mouth (oral) cancer

Status:

Open

Phase:

Other

This study is looking at 2 different ways of giving radiotherapy alongside chemotherapy for people with locally advanced head and neck cancer.

Locally advanced means the cancer has spread from where it started into nearby body tissues or lymph nodes Open a glossary item but has not spread to other areas of the body.

This study is for people with cancer of the

Diagram showing the position of the oropharynx and hypopharynx

More about this trial

If you have locally advanced head and neck cancer you usually have treatment with a combination of chemotherapy and radiotherapy. This is called chemoradiotherapy or chemoradiation. Some chemotherapy drugs help to make the cells more sensitive to the radiotherapy.

The most common drug used is cisplatin. You have it during the radiotherapy course, usually every 3 weeks.

When doctors plan radiotherapy, they work out how much radiation you need to treat the cancer and exactly where you need it. Cancer cells can spread into the tissues close to the tumour so your radiotherapy specialist will decide on the exact area to be treated around the cancer. They will also make allowances for possible movement of the tumour during treatment such as when you breathe or normal movement of body organs. So, there is always a margin of normal healthy tissue in the radiotherapy area.

Research has shown that having a higher dose of radiotherapy to a head a neck cancer makes it is less likely to come back. But the dose of radiation using standard radiotherapy is limited because of the increased risk of side effects from giving too much radiotherapy to the healthy tissue (the margin).

In this study the doctors want to compare giving standard radiotherapy with higher dose radiotherapy. The doctors will use a PET scan to help them target the areas where they will give a higher dose.

Part of the study is also looking at changes in proteins and genes (Biomarkers Open a glossary item) in your blood and, if possible, a sample of your cancer.

Looking at biomarkers helps the doctors know how well your treatment is working and could also help to develop better treatment choices in the future.

The aims of the study are to

  • See which type of radiotherapy is better for locally advanced head and neck cancer
  • Find out more about the side effects of the treatments
  • Discover whether biomarkers can help predict who will benefit from these treatments

Who can enter

The following bullet points list the entry conditions for this study. If you are unsure about any of these speak with your doctor or the study team. They will be able to advise you.

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

  • You have been diagnosed with a locally advanced squamous cell cancer Open a glossary itemof your oropharynx, mouth or hypopharynx that has not spread elsewhere in the body
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood results
  • You are willing to use reliable contraception for 2 weeks before starting chemotherapy and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant
  • You are aged between 18 and 70

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

  • Have already had surgery, radiotherapy or chemotherapy for your head and neck cancer
  • Are due to have any other anti cancer treatment during the time of the study
  • Have had an experimental drug in the 4 weeks before starting the study or are due to have an experimental drug during the time of the study
  • Have ever had the chemotherapy drug cisplatin
  • Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or basal cell carcinoma that was successfully treated
  • Have a serious fungal, bacterial or viral infection which is causing symptoms
  • Have HIV
  • Have any other serious medical condition or mental health problem that the study team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is an international trial. The doctors need 20 people in the UK to take part.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

There are 2 treatment groups

  • One group have standard radiotherapy once a day, Monday to Friday, for 7 weeks and cisplatin once every 3 weeks
  • The other group have targeted radiotherapy once a day, Monday to Friday, for 7 weeks and cisplatin once every 3 weeks

Diagram for ARTFORCE

You have cisplatin before you have your radiotherapy. You have the cisplatin as a drip into the vein overnight. You have it on the 1st day of treatment and then at 3 week intervals. You have 3 lots in total.

The study team will ask you to fill out some questionnaires before and at the end of treatment and then 6 and 12 months later. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

The researchers will also ask for a sample of your cancer (biopsy Open a glossary item) that was removed when you were diagnosed. This is so they can look at biomarkers Open a glossary item.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • Blood tests
  • Physical examination
  • CT scan or MRI scan of your head and neck
  • PET-CT scan of your head and neck and upper tummy (abdomen)
  • Ultrasound scan of your neck
  • Heart trace (ECG Open a glossary item)
  • Hearing test (audiometry)
  • Dental check

Some people taking part may also need to have a feeding tube, in case of problems swallowing. Your doctor will discuss this with you if this if you need a tube.

During treatment you

  • Go to hospital once a day, Monday to Friday for your radiotherapy
  • You have cisplatin overnight once every 3 weeks
  • See the doctor or a research nurse so they can ask how you are and you have a physical examination weekly
  • Have a blood test once a week

In the 2nd week of treatment you have a PET-CT and CT scan to check how the treatment is working.

After you finish treatment you see the study team weekly for 3 weeks and have a blood test once a week.

10 to 12 weeks after you have finished treatment you see the doctor or research nurse so they can ask how you are and you have a

  • PET-CT scan
  • CT or MRI scan
  • Ultrasound of your neck
  • Hearing test

You then see the study team every 3 months until 2 years after you finished treatment.

Between 3 and 5 years following treatment you see the doctors every 6 months. After 5 years you have routine care and will have the most appropriate clinic visits.

Side effects

The side effects of cisplatin include

  • An increased risk of getting an infection from a drop in white blood cells
  • An effect on the way your kidneys work, to help prevent this it is important to drink plenty of water. You will also have extra fluids into your vein when you have the cisplatin
  • Possible hearing loss, especially with high pitched sounds
  • Numbness and tingling in your hands and feet (peripheral neuropathy)
  • Feeling or being sick  

The side effects from radiotherapy include

  • Feeling or being sick
  • Sore, painful mouth
  • Difficulty swallowing

We have more information about

Location

Manchester

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 Lip Lee

Supported by

European Commission
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Christie NHS Foundation Trust
The Netherlands Cancer Institute

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11560

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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