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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Andrew McPartlin, MD
andrew.mcpartlin@rmp.uhn.ca
416-946-2132
Time Frame
Start Date: 2025-04-17
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Arm 1: Integrated Boost Radiotherapy
External beam radiotherapy 70Gy in 35 fractions to head and neck tumour and 56 Gy in 35 fraction to elective nodal regions. This will be given as single integrated boost or two-phase treatment at clinician discretion.
Active_comparator: Arm 2: Two Phase Radiotherapy
Standard of care external beam radiotherapy 70 Gy in 35 fractions to head and neck with delayed 40 Gy in 20 fractions to elective nodal regions. This will be given as reversed two-phase treatment.
Related Therapeutic Areas
Head and Neck Squamous Cell Carcinoma (HNSCC)
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov

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