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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
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-04-17
Completion Date
2028-08-01
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Princess Margaret Cancer Centre
Toronto, Ontario, Canada