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New radiation technique may improve cancer control in advanced head and neck cancer

NCT ID NCT06641791

Disease control Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study compares a newer, precise radiation method called stereotactic body radiotherapy (SBRT) with standard radiation therapy for people with advanced head and neck cancer who cannot have curative treatment. About 196 adults will be randomly assigned to one of the two radiation approaches. The main goal is to see if SBRT helps people live longer and better controls the cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 196 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary * Stages TX or T0-T4/N0-N3 * Must be considered unfit for curative intent RT as determined by the treating oncologist(s) * Geriatric 8 score \<14 * Patient must be ≥18 years of age * Staging CT or MRI of the head and neck within 8 weeks prior to randomization * Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 * Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy. * Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial. Exclusion Criteria: * Patients with nasopharyngeal carcinoma. * Prior systemic therapy (including immunotherapy). * Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment. * Prior head and neck cancer excluding skin cancer. * Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic structures, any single tumour mass \>8 cm (in one dimension). * \> 2 nodal levels (Level 1a/b not counted); retropharyngeal lymph nodes (where the closest edge is \< 2cm from the closest edge of CTV (primary or nodal) will not be considered as a different level). Note: a single lymph node mass that spans 2 levels will be considered as 1 level. * Gross tumour poorly visualized on CT/MRI. * Definitive radiological or clinically evident distant metastases. * Scleroderma/CREST syndrome.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced head and neck cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arthur J.E. Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • BCCA - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Hotel-Dieu de Quebec

    RECRUITING

    Québec, Quebec, G1R 2J6, Canada

  • Odette Cancer Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

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