Recruiting

HN-BIO 02

Sponsor:

University Health Network, Toronto

Code:

NCT06487403

Conditions

Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of care external beam radiotherapy (single integrated boost)

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

Study Details

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

Study ID

NCT06487403

Start date

Apr 17, 2025

Status verified date

Mar, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 (HPV+ oropharynx) or 50 Gy/25 (all other disease) to elective nodal regions. This will be given as reversed two-phase treatment.

Interventions

Standard of care external beam radiotherapy (single integrated boost)

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

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

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

Primary outcome measure

  • Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes [ Time Frame: 7 weeks ]
  • Change in fMRI during radiotherapy [ Time Frame: 7 weeks ]
  • Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy. [ Time Frame: 7 weeks ]

Central Contacts and Locations

Central contacts

Andrew McPartlin, MD

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

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Andrew McPartlin, MD

(416) 946-4501 x 4855andrew.mcpartlin@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-04.