Tests timing of radiotherapy in people with head and neck squamous cell carcinoma
Compares delayed and standard radiation timing in adults with newly diagnosed head and neck cancer.
Plain-language title generated from the registry record
Registry title: HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
Key facts
- Where
- Toronto, CanadaSee the site
Where in Canada
- Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT06487403
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers
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.
Inclusion: 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: Currently participating in another study that requires standard of care radiotherapy; Previous solid tumor treated within last 5 years that investigator feels makes unsuitable for study; As judged by investigator evidence of systemic disease that makes unsuitable for study; History of gadolinium contrast allergy; History of significant respiratory disease; More than one contralateral nodal level requiring treatment in phase I; As judged by investigator, it is deemed unsafe or medically inadvisable to conduct repeat biopsies; Contra-indication for serial MRI scans; Pregnancy; Non-reversible clotting abnormality.