This is a single centre prospective exploratory study of effects of delayed radiation therapy on adaptive immune response in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative radiotherapy. This research is part 2 of the HN-BIO study.
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
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
Parallel
Standard of care external beam radiotherapy (single integrated boost)
Radiation70Gy 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)
Radiation70Gy in 35 fractions, delayed 40 Gy in 20 fractions or 50 Gy in 25 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.
Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes
Achieve a minimum recruitment rate of one patient per month.
Change in fMRI during radiotherapy
Study association of changes in fMRI and tissue biomarkers during radiotherapy. Assessed through hypoxic regions visible on imaging scans.
Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy.
Assess effect of varying radiotherapy treatment volumes on changes in tumor microenvironment via repeat biopsy before and during radiotherapy. Quantify effect of delayed treatment of dLN on dynamic changes tumor immune micro-environment and hypoxia status during radiotherapy. Perform exploratory analysis of study data correlating changes in tumor microenvironment and hypoxia status with disease response to therapy.
Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC
Correlate changes in TME and hypoxia with changes in fMRI on repeat assessment. Correlate fMRI characterized tumor with pathological post-operative specimen.
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