Advanced Head and Neck CancerPhase 3NCT06641791
Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
A Phase 3 study testing Standard Radiotherapy (SRT) and Stereotactic Body Radiotherapy (SBRT) in people with Advanced Head and Neck Cancer, run by Canadian Cancer Trials Group at 10 sites in Canada.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Head and Neck Cancer
- What is being tested?
- Standard Radiotherapy (SRT) and Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 10 sitesCanada
- Study dates
- 7 Apr 2025to 1 Jun 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- Gross tumour poorly visualized on CT/MRI.
- Definitive radiological or clinically evident distant metastases.
- Scleroderma/CREST syndrome.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Canada10 sites, 10 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Robyn Banerjee, 403 955-7641
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Brock Debenham, 780 432-8754
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
James R. Wright, 905 387-9495
- Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Houda Bahig, 514 890-8000 ext. 11185
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Ionut Busca, 613 261-5398
- Recruiting
Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Patrick Martin
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Ian D.T. Poon, 416 480-4974
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Chiaojung Jillian Tsai, 416 946-4501
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Matthew Ryan Chan, 604 877-6000 ext. 672461
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Carlton Johnny, 204 787-2153
About this study
Official title: 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?
Read the 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.
- Conditions
- Advanced Head and Neck Cancer
- Being tested
- Standard Radiotherapy (SRT), Stereotactic Body Radiotherapy (SBRT)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Radiotherapy (SRT)Radiation
2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week
Stereotactic Body Radiotherapy (SBRT)Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Radiotherapy (SRT) | Active comparator | Not described Receives: Radiation: Standard Radiotherapy (SRT) |
| Stereotactic Body Radioterapy (SBRT) | Experimental | Not described Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival estimated according to Kaplan-Meier's methodology
Measured: 6 years
Secondary outcomes (7)
Progression-free Survival
Measured: 6 years
Local Regional Failure Free Survival
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.
Measured: 6 years
Response Rate evaluated by RECIST
Measured: 6 years
Number and Severity of Adverse Events
Measured: 6 years
Patient Reported Outcomes utilizing PRO-CTCAE
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.
Measured: 6 years
Patient Reported Outcomes utilizing FACT-HN
proportion of patients between arms who have a meaningful worsening (12 points or greater) of QOL
Measured: 6 years
Healthcare Resource Utilization utilizing EQ-5D-5L
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start7 Apr 2025
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Ian Poon, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641791
- Sponsor's protocol ID
- HN13
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06641791
- Acronym / sponsor ID
- HN13
- Conditions
- Advanced Head and Neck Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Radiotherapy (SRT) | Active comparator | Radiation: Standard Radiotherapy (SRT) |
| Stereotactic Body Radioterapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Radiotherapy (SRT)2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week | Radiation | Standard Radiotherapy (SRT) |
| 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. | Radiation | Stereotactic Body Radioterapy (SBRT) |
Primary outcome
Overall Survival estimated according to Kaplan-Meier's methodology
Time frame: 6 years
7 secondary outcomes
Progression-free Survival
Time frame: 6 years
Local Regional Failure Free Survival
Time frame: 6 years
Response Rate evaluated by RECIST
Time frame: 6 years
Number and Severity of Adverse Events
Time frame: 6 years
Patient Reported Outcomes utilizing PRO-CTCAE
Time frame: 6 years
Patient Reported Outcomes utilizing FACT-HN
Time frame: 6 years
Healthcare Resource Utilization utilizing EQ-5D-5L
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Poon study chair
Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Radiotherapy (SRT) and Stereotactic Body Radiotherapy (SBRT) in people with Advanced Head and Neck Cancer, run by Canadian Cancer Trials Group at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Parulekar (613-533-6430, wparulekar@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival estimated according to Kaplan-Meier's methodology (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.