All studies
Active not recruitingPHASE2INTERVENTIONAL

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

This study is for people with a specific type of throat cancer, called oropharyngeal cancer, which is linked to the HPV virus. Standard treatments, such as radiation or chemotherapy, are very good at curing this cancer, but they can cause side effects both in the short term and over many years. Researchers want to find out if it's possible to give a bit less radiation treatment to certain parts of the neck. The main goal is to protect patients from some of these side effects, while still making sure the cancer doesn't return. This could lead to a kinder way to treat this cancer in the future.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Canadian Cancer Trials Group
Enrolment target
103
Start
28 Jun 2019
Estimated completion
31 Dec 2026

Results

Results from this study

Posted September 2025

Results have been published for this study.

Primary outcome
Event-free Survival
Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events: * Progression. * Surgery. * Non-protocol RT, chemotherapy, or biologic therapy (for the current cancer diagnosis) without documentation of the site of failure. * Death due to any cause. The outcome is reported as the proportion of patients who remain event-free at 2 years.
Full results on the registry

What is this study about?

If you have a type of throat cancer called oropharyngeal cancer that's linked to the HPV virus, you might be interested in this study. Currently, the usual treatments for this cancer, which often involve radiation therapy — sometimes along with chemotherapy or other medicines — are very effective. They cure most people.

However, these strong treatments can also lead to side effects. Some side effects might happen soon after treatment, while others can affect people for many years. These can include things like a dry mouth, difficulty swallowing, or changes to your voice or taste. The researchers running this study want to see if they can reduce the amount of radiation given to certain areas of the neck where the cancer may not be present.

The main idea is to find out if reducing the radiation in this way can safely lower the risk of these side effects, without making the cancer more likely to come back. This means patients might have a better quality of life during and after treatment. If successful, this study could change how this type of cancer is treated in the future, making it easier on patients.

Key takeaways

  • Looks at reducing radiation for HPV-related throat cancer.
  • Aims to lessen treatment side effects while still being effective.
  • Specifically for early-stage oropharyngeal cancer linked to HPV.
  • Could improve quality of life for patients after treatment.
  • Involves regular check-ups and questionnaires.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of oropharyngeal cancer that's linked to the HPV virus. Your cancer should be at an early stage (T1-3 N0-1 M0), and you must be considered suitable for either radiation alone or radiation combined with other treatments.

You also need to be at least 18 years old and generally well enough to take part. This is checked using a specific health score called an ECOG performance status (this score should be 0, 1, or 2). You should be able to speak either English or French well enough to fill out questionnaires about your quality of life.

Before joining, you'll need to give your permission by signing a consent form. If you're a woman who could have children, or a man who could father children, you'll need to agree to use effective contraception during the study. You’ll also need to have some specific scans of your head, neck, and body done within 8 weeks before starting treatment, and be willing to provide tissue and blood samples for further tests.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have HPV-related oropharyngeal cancer?
  2. Is my cancer at an early stage (T1-3 N0-1 M0)?
  3. Am I at least 18 years old?
  4. Am I generally well enough to participate?
  5. Can I speak English or French to complete questionnaires?
  6. Am I willing to provide tissue and blood samples?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be giving permission for researchers to look more closely at your cancer tissue and blood samples. This helps them understand more about your cancer and how treatments work. You'll also need to fill out questionnaires about your health and how you're feeling, both in English or French.

The actual treatment you receive will involve radiation, but the study is designed to see if a slightly different, potentially reduced, radiation approach works as well as the standard treatment. The total length of your participation, including follow-up appointments, will depend on your treatment plan and the specific monitoring schedule. The study aims to get you started with treatment within three weeks of signing up, and you'll need to be available for regular check-ups to make sure the treatment is working and to monitor any side effects.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new, potentially gentler radiation treatment that could lead to fewer or less severe side effects. However, there's always a possibility that the reduced radiation might not be as effective as standard treatment, although the study is carefully designed to minimise this risk. As with any medical treatment, there can be unexpected side effects from the radiation or other medications. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (14)

  • BCCA - Centre for the North
    Verified postcode
    Prince George, Canada
  • BCCA - Vancouver Cancer Centre
    Verified postcode
    Vancouver, Canada
  • CancerCare Manitoba
    Verified postcode
    Winnipeg, Canada
  • Dr. H. Bliss Murphy Cancer Centre
    Verified postcode
    St. John's, Canada
  • Juravinski Cancer Centre at Hamilton Health Sciences
    Verified postcode
    Hamilton, Canada
  • Kingston Health Sciences Centre
    Verified postcode
    Kingston, Canada
  • Ottawa Hospital Research Institute
    Verified postcode
    Ottawa, Canada
  • Odette Cancer Centre
    Verified postcode
    Toronto, Canada
  • University Health Network
    Verified postcode
    Toronto, Canada
  • The Jewish General Hospital
    Verified postcode
    Montreal, Canada
  • The Research Institute of the McGill University
    Verified postcode
    Montreal, Canada
  • Hotel-Dieu de Quebec
    Verified postcode
    Québec, Canada

Common questions

What is HPV-related oropharyngeal cancer?

It's a type of throat cancer that has been linked to the Human Papillomavirus (HPV).

Why is this study called 'de-escalation'?

It means the researchers are looking to 'step down' or reduce the intensity of some of the usual treatment, in this case, radiation.

Will I still get effective treatment for my cancer?

Yes, the study is carefully designed to find a balance between effective cancer control and reducing potential side effects.

What kind of side effects are they trying to reduce?

Common side effects from radiation to the head and neck can include dry mouth, difficulty swallowing, and changes in taste, among others.

Do I have to live close to the treatment centre?

You need to be able to get to the treatment centre regularly for your appointments and follow-up, so being accessible is important.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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