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
Inclusion Criteria9
- 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 Criteria6
- 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
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)
View Full Details on ClinicalTrials.gov
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NCT06487403
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