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

NCT06487403 | Recruiting

• 1 other identifier: 24-5510
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (3)

• 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.

  7 weeks

• Change in fMRI during radiotherapy

  Study association of changes in fMRI and tissue biomarkers during radiotherapy. Assessed through hypoxic regions visible on imaging scans.

  7 weeks

• 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.

  7 weeks

Secondary Outcomes (1)

• Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC

  7 weeks

Study Arms (2)

Arm 1: Integrated Boost Radiotherapy

ACTIVE COMPARATOR

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.

Radiation: Standard of care external beam radiotherapy (single integrated boost)

Arm 2: Two Phase Radiotherapy

ACTIVE COMPARATOR

Standard of care external beam radiotherapy 70 Gy in 35 fractions to head and neck with delayed 40 Gy in 20 fractions (HPV+ oropharynx) or 50 Gy/25 (all other disease) to elective nodal regions. This will be given as reversed two-phase treatment.

Radiation: Standard of care external beam radiotherapy (two-phase treatment)

Interventions

Standard of care external beam radiotherapy (single integrated boost) RADIATION

70Gy in 35 fractions, 56 Gy in 35 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.

Arm 1: Integrated Boost Radiotherapy

Standard of care external beam radiotherapy (two-phase treatment) RADIATION

70Gy in 35 fractions, delayed 40 Gy in 20 fractions or 50 Gy in 25 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.

Arm 2: Two Phase Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Andrew McPartlin, MD

CONTACT

416-946-2132; andrew.mcpartlin@rmp.uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: April 17, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CA (1)