Clinical trial NCT06487403: HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative therapy. 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 a blood draw will be performed.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes
timeFrame: 7 weeks
measure: Change in fMRI during radiotherapy
timeFrame: 7 weeks
measure: Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy.
timeFrame: 7 weeks
Secondary outcomes:
measure: Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: