A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

Trial Title: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

NCT ID: NCT06487403

Condition: Squamous Cell Carcinoma of Head and Neck

Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Standard of care external beam radiotherapy (single integrated boost)
Description: 70Gy in 35 fractions, 56 Gy in 35 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.
Arm group label: Arm 1: Integrated Boost Radiotherapy

Intervention type: Radiation
Intervention name: Standard of care external beam radiotherapy (two-phase treatment)
Description: 70Gy in 35 fractions, delayed 40 Gy in 20 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.
Arm group label: Arm 2: Two Phase Radiotherapy

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Princess Margaret Cancer Center

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Start date: August 1, 2024

Completion date: August 1, 2027

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06487403