RecruitingNot ApplicableNCT06487403

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers


Sponsor

University Health Network, Toronto

Enrollment

40 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This randomized study is looking at whether a short delay before starting radiation therapy affects the tumor's characteristics on MRI scans and the body's immune response in people with head and neck squamous cell carcinoma (mouth, throat, or voice box cancer). **You may be eligible if...** - You are 18 or older - You have been diagnosed with head and neck squamous cell cancer confirmed by tissue biopsy - Your primary tumor or involved lymph nodes are larger than 3 cm - You are planned for either surgery or chemoradiotherapy with curative intent - You are willing to have repeat MRI scans - Your kidney function is adequate (creatinine clearance at least 30 mL/min) - You can comfortably lie on your back for 1 hour **You may NOT be eligible if...** - You have a systemic illness that makes you unsuitable for the study - You are unable to have MRI scans - You have had another solid tumor treated within the last 5 years - You are pregnant - You have a gadolinium (MRI contrast dye) allergy - You have a blood clotting disorder that cannot be reversed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStandard 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.

RADIATIONStandard 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.


Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT06487403


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