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A head and neck clinical trial - HN13

A study comparing two kinds of radiation therapy in patients with advanced head and neck cancer
Disease Site
Head and Neck Clinical Trials
Trial Code
HN.13 ǀ NCT06641791
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to compare the effects on you and your head and neck cancer of a new type of radiation treatment compared with standard radiation therapy.

Why is this study important?

The new type of radiation treatment being studied is called stereotactic body radiotherapy (SBRT). This treatment has been studied in people with different types of cancer. There is some evidence that it may shrink tumours in people with head and neck cancer, but it is not clear if it can offer better results than standard radiotherapy treatment.

Who can participate in this study?

This trial is for people:

  • with head and neck cancer, who have not received any other treatment
  • physically unable to receive other treatment that may cure their cancer 
  • 18 years of age or older
  • available for follow-up visits
     

This trial is not for people:

  • whose cancer has spread to different parts of their body
  • with Scleroderma/CREST Syndrome
     
What are the risks?
  • If you choose to take part in this study, there is a risk that SBRT may not be as good as standard radiotherapy. There is also a risk that you could have side effects from the SBRT that may be worse or different than the side effects from standard radiotherapy. Some of the most common side effects that the study doctors know about are: 
    • Peeling and redness of skin in the area being treated
    • Trouble swallowing and painful swallowing due to sores in your mouth and throat 
    • Pain flare (the pain caused by your disease that you already have gets slightly worse)
    • Fatigue 
    • Damage to other organs that receive radiotherapy which is directed at your tumour.
  • You will find details of all side effects in the consent document.
What can I expect?
  • If you choose to take part in this study, you will be randomly placed in one of two groups and you will receive either the new type of radiation therapy or the radiation treatment that is commonly used in this disease.
  • In this study, you will also be asked to complete a few questionnaires at different times, to understand your Quality of Life.
     

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The HN.13 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT06641791.

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.