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

ConditionSquamous Cell Carcinoma of Head and Neck

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Health Network, Toronto

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Standard of care external beam radiotherapy (single integrated boost)
Standard of care external beam radiotherapy (two-phase treatment)

Treatment groups

40 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov