Effects of Delayed Elective Radiotherapy on Head and Neck Cancer Biomarkers
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 study is testing whether starting radiation therapy later helps people with newly diagnosed head and neck cancer by looking at changes in their tumors and immune markers during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06487403 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of delayed elective radiotherapy on biomarker development in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) undergoing curative treatment. Up to 40 patients will be randomized to receive either conventional radiotherapy or a reversed two-phase treatment with delayed irradiation. Participants will undergo functional MRI scans and biopsies at baseline and during treatment to assess changes in tumor response and immune biomarkers. The study aims to enhance understanding of treatment effects on tumor biology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed head and neck squamous cell carcinoma and a primary or nodal disease greater than 3 cm.
Not a fit: Patients with systemic diseases, contraindications for MRI, or those who have had previous solid tumors treated within the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for head and neck cancer by optimizing radiotherapy timing and enhancing patient outcomes.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in understanding the effects of radiotherapy on tumor biology, though this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Andrew McPartlin, MD
- Email: andrew.mcpartlin@rmp.uhn.ca
- Phone: 416-946-2132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.