Squamous Cell Carcinoma of Head and NeckHN-Bio 02NCT06487403
HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
A study of Squamous Cell Carcinoma of Head and Neck, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single centre prospective exploratory study of effects of delayed radiation therapy on adaptive immune response in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative radiotherapy. This research is part 2 of the HN-BIO study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2025to 1 Aug 2028
- Phase
- Interventional
- 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
- Age >/= 18 years
- Histologically proven Head and Neck Squamous Cell carcinoma
- Primary or nodal disease > 3cm for biomarker imaging
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Planned for curative surgery or (chemo)radiotherapy
- Willingness to undergo repeat MRI imaging
Show all 9Show fewer
- Able to receive and understand verbal and written information regarding study and able to -give written informed consent
- Adequate renal function: Calculated creatinine clearance >/= 30ml/min
- Be able to lie comfortably on back for 1 hour
Who cannot join
- As judged by investigator evidence of systemic disease that makes unsuitable for study
- Contra-indication for serial MRI scans
- Previous solid tumor treated within last 5 years
- Pregnancy
- History of gadolinium contrast allergy
- Non-reversible clotting abnormality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Andrew McPartlin, MD, (416) 946-4501 x 4855, andrew.mcpartlin@uhn.ca
About this study
This is a single centre prospective exploratory study of effects of delayed radiation therapy on adaptive immune response in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative radiotherapy. This research is part 2 of the HN-BIO study.
Read the detailed description
This study will recruit up to 40 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) HNSCC with primary tumor and/or involved lymph node suitable for repeat biopsy in clinic. After being informed about the study and potential risks, patients giving written informed consent will be randomized to receive conventional radiotherapy (single integrated boost or conventional two-phase at clinician discretion) or reversed two-phase treatment with delayed irradiation of elective nodal volumes. Patients will not be informed of their randomization result.
Patients in both arms will undergo a baseline functional magnetic resonance imaging (fMRI) scan, , and within 72 hours, when possible, a biopsy of the primary tumor +/- lymph node will be performed in an out-patient clinic. If a suitable biopsy has been recently performed as part of diagnostic work up the baseline biopsy on study will be omitted when possible. In week 2 of radiotherapy, patients will have a second fMRI scan and a paired biopsy within 72 hours of the scan, where possible. A further optional biopsy and paired fMRI scan in week 4 will be considered for patients who are tolerating therapy without >G1 toxicities. 16-24 hours prior to each biopsy the patient will take oral pimonidazole. At the time of each biopsy and six weeks post completion of radiotherapy a blood draw will be performed to assess lymphocyte preservation and evidence of differential immune activation.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Standard of care external beam radiotherapy (single integrated boost), Standard of care external beam radiotherapy (two-phase treatment)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care external beam radiotherapy (single integrated boost)Radiation
70Gy in 35 fractions, 56 Gy in 35 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.
Standard of care external beam radiotherapy (two-phase treatment)Radiation
70Gy in 35 fractions, delayed 40 Gy in 20 fractions or 50 Gy in 25 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Integrated Boost Radiotherapy | Active comparator | External beam radiotherapy 70Gy in 35 fractions to head and neck tumour and 56 Gy in 35 fraction to elective nodal regions. This will be given as single integrated boost or two-phase treatment at clinician discretion. Receives: Radiation: Standard of care external beam radiotherapy (single integrated boost) |
| Arm 2: Two Phase Radiotherapy | Active comparator | Standard of care external beam radiotherapy 70 Gy in 35 fractions to head and neck with delayed 40 Gy in 20 fractions (HPV+ oropharynx) or 50 Gy/25 (all other disease) to elective nodal regions. This will be given as reversed two-phase treatment. Receives: Radiation: Standard of care external beam radiotherapy (two-phase treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes
Achieve a minimum recruitment rate of one patient per month.
Measured: 7 weeks
Change in fMRI during radiotherapy
Study association of changes in fMRI and tissue biomarkers during radiotherapy. Assessed through hypoxic regions visible on imaging scans.
Measured: 7 weeks
Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy.
Assess effect of varying radiotherapy treatment volumes on changes in tumor microenvironment via repeat biopsy before and during radiotherapy. Quantify effect of delayed treatment of dLN on dynamic changes tumor immune micro-environment and hypoxia status during radiotherapy. Perform exploratory analysis of study data correlating changes in tumor microenvironment and hypoxia status with disease response to therapy.
Measured: 7 weeks
Secondary outcomes (1)
Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC
Correlate changes in TME and hypoxia with changes in fMRI on repeat assessment. Correlate fMRI characterized tumor with pathological post-operative specimen.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start17 Apr 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487403
- Sponsor's protocol ID
- 24-5510
- Acronym
- HN-Bio 02
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
- ClinicalTrials.gov ID
- NCT06487403
- Acronym / sponsor ID
- HN-Bio 02 / 24-5510
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 5 Jul 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 is a single centre prospective exploratory study of effects of delayed radiation therapy on adaptive immune response in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative radiotherapy. This research is part 2 of the HN-BIO study.
Detailed description
This study will recruit up to 40 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) HNSCC with primary tumor and/or involved lymph node suitable for repeat biopsy in clinic. After being informed about the study and potential risks, patients giving written informed consent will be randomized to receive conventional radiotherapy (single integrated boost or conventional two-phase at clinician discretion) or reversed two-phase treatment with delayed irradiation of elective nodal volumes. Patients will not be informed of their randomization result.
Patients in both arms will undergo a baseline functional magnetic resonance imaging (fMRI) scan, , and within 72 hours, when possible, a biopsy of the primary tumor +/- lymph node will be performed in an out-patient clinic. If a suitable biopsy has been recently performed as part of diagnostic work up the baseline biopsy on study will be omitted when possible. In week 2 of radiotherapy, patients will have a second fMRI scan and a paired biopsy within 72 hours of the scan, where possible. A further optional biopsy and paired fMRI scan in week 4 will be considered for patients who are tolerating therapy without >G1 toxicities. 16-24 hours prior to each biopsy the patient will take oral pimonidazole. At the time of each biopsy and six weeks post completion of radiotherapy a blood draw will be performed to assess lymphocyte preservation and evidence of differential immune activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Integrated Boost Radiotherapy | Active comparator | Radiation: Standard of care external beam radiotherapy (single integrated boost)External beam radiotherapy 70Gy in 35 fractions to head and neck tumour and 56 Gy in 35 fraction to elective nodal regions. This will be given as single integrated boost or two-phase treatment at clinician discretion. |
| Arm 2: Two Phase Radiotherapy | Active comparator | Radiation: Standard of care external beam radiotherapy (two-phase treatment)Standard of care external beam radiotherapy 70 Gy in 35 fractions to head and neck with delayed 40 Gy in 20 fractions (HPV+ oropharynx) or 50 Gy/25 (all other disease) to elective nodal regions. This will be given as reversed two-phase treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >/= 18 years
- Histologically proven Head and Neck Squamous Cell carcinoma
- Primary or nodal disease > 3cm for biomarker imaging
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Planned for curative surgery or (chemo)radiotherapy
Key exclusion criteria (6 listed)
- As judged by investigator evidence of systemic disease that makes unsuitable for study
- Contra-indication for serial MRI scans
- Previous solid tumor treated within last 5 years
- Pregnancy
- History of gadolinium contrast allergy
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 of care external beam radiotherapy (single integrated boost)70Gy in 35 fractions, 56 Gy in 35 fractions. Oral Pimonidazole 200 mg and 300 mg tablets. | Radiation | Arm 1: Integrated Boost Radiotherapy |
| Standard of care external beam radiotherapy (two-phase treatment)70Gy in 35 fractions, delayed 40 Gy in 20 fractions or 50 Gy in 25 fractions. Oral Pimonidazole 200 mg and 300 mg tablets. | Radiation | Arm 2: Two Phase Radiotherapy |
Primary outcome
Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes
Time frame: 7 weeks
Achieve a minimum recruitment rate of one patient per month.
Change in fMRI during radiotherapy
Time frame: 7 weeks
Study association of changes in fMRI and tissue biomarkers during radiotherapy. Assessed through hypoxic regions visible on imaging scans.
Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy.
Time frame: 7 weeks
Assess effect of varying radiotherapy treatment volumes on changes in tumor microenvironment via repeat biopsy before and during radiotherapy. Quantify effect of delayed treatment of dLN on dynamic changes tumor immune micro-environment and hypoxia status during radiotherapy. Perform exploratory analysis of study data correlating changes in tumor microenvironment and hypoxia status with disease response to therapy.
1 secondary outcome
Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC
Time frame: 7 weeks
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 11 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Squamous Cell Carcinoma of Head and Neck, run by University Health Network, Toronto at 1 site 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 9 inclusion and 6 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Andrew McPartlin, MD (416-946-2132, andrew.mcpartlin@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes (time frame: 7 weeks). The study lists 3 primary outcomes in all. 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 11 Sep 2026.