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Radiation

Arm 1: Integrated Boost Radiotherapy for Squamous Cell Carcinoma (HN-Bio 02 Trial)

N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age \>/= 18 years
* Histologically proven Head and Neck Squamous Cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights

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.

Who is the study for?
This trial is for individuals with newly diagnosed head and neck squamous cell carcinoma (HNSCC) who are about to receive curative radiation therapy. Specific eligibility criteria details were not provided, so it's best to contact the study organizers for more information.
What is being tested?
The study explores how standard external beam radiotherapy affects biomarker development in HNSCC patients. It compares two methods: a single integrated boost versus a two-phase treatment approach.
What are the potential side effects?
While specific side effects aren't listed, external beam radiotherapy can generally cause skin reactions, fatigue, dry mouth, difficulty swallowing, and changes in taste.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy.
Change in fMRI during radiotherapy
Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes
Secondary study objectives
Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC

Trial Design

2Treatment groups
Active Control
Group I: Arm 1: Integrated Boost RadiotherapyActive Control1 Intervention
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.
Group II: Arm 2: Two Phase RadiotherapyActive Control1 Intervention
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.

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Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,513 Previous Clinical Trials
499,845 Total Patients Enrolled
~27 spots leftby Aug 2026
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