Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

May 11, 2026 updated by: Canadian Cancer Trials Group

A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stereotactic body radiation therapy, or SBRT, is a cancer treatment that more precisely delivers radiation to the tumour area with less radiation going to unaffected areas around the tumour. It uses fewer treatments of higher doses compared to standard radiation therapy.

This study is being done to find out if this approach is better than the usual approach for advanced head and neck cancer. The usual approach is defined as care most people get for advanced head and neck cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
        • Contact:
          • Robyn Banerjee
          • Phone Number: 403 955-7641
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Brock Debenham
          • Phone Number: 780 432-8754
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
          • Carlton Johnny
          • Phone Number: 204 787-2153
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
          • Ionut Busca
          • Phone Number: 613 261-5398
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network
        • Contact:
          • Chiaojung Jillian Tsai
          • Phone Number: 416 946-4501
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Odette Cancer Centre
        • Contact:
          • Ian D.T. Poon
          • Phone Number: 416 480-4974
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • CHUM-Centre Hospitalier de l'Universite de Montreal
        • Contact:
          • Houda Bahig
          • Phone Number: 11185 514 890-8000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Radiotherapy (SRT)
Radiation: Standard Radiotherapy (SRT)
2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week
Experimental: Stereotactic Body Radioterapy (SBRT)
Radiation: Stereotactic Body Radiotherapy (SBRT)
4500 cGy in 5 fractions (twice a week to primary and nodal GTV, OR, 4000 cGy in 5 fractions twice a week if organs at risk.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival estimated according to Kaplan-Meier's methodology
Time Frame: 6 years
6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: 6 years
6 years
Local Regional Failure Free Survival
Time Frame: 6 years

defined as the time from the date of randomization to the date of any of the following, whichever comes first:

  • The first record of appearance (radiological or clinical) of local or regional disease progression/recurrence.
  • Surgery of primary tumour at any time performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology.
  • Neck dissection > 20 weeks from the end of radiation therapy performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology.
6 years
Response Rate evaluated by RECIST
Time Frame: 6 years
6 years
Number and Severity of Adverse Events
Time Frame: 6 years
6 years
Patient Reported Outcomes utilizing PRO-CTCAE
Time Frame: 6 years
We will qualitatively compare PRO-CTCAE item scores between arms at 8 weeks from the start of RT, and examine PRO-CTCAE item scores at 12 months post-RT in the SBRT arm, as an indicator or persisting (consequential or "late") RT toxicity with SBRT to the head and neck region.
6 years
Patient Reported Outcomes utilizing FACT-HN
Time Frame: 6 years
proportion of patients between arms who have a meaningful worsening (12 points or greater) of QOL
6 years
Healthcare Resource Utilization utilizing EQ-5D-5L
Time Frame: 6 years
All enrolled participants who have received at least one fraction of protocol therapy are evaluable for health economics. Those who have completed the Health Utilities Index (EQ-5D-5L), will be evaluable for cost-utility analyses.
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canadian Cancer Trials Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ian Poon, Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HN13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As per CCTG Policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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