Actively Recruiting
Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2020-09-04
68
Participants Needed
1
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.
CONDITIONS
Official Title
Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing to provide informed consent
- ECOG performance status between 0 and 2
- Histologically confirmed squamous cell carcinoma
- HPV-negative tumor confirmed by negative p16 status, PCR, or in-situ hybridization; equivocal HPV status allowed
- Primary tumor located in the oropharynx (tonsil, soft palate, base of tongue, oropharynx walls)
- Tumor stage T1 or T2 with likely negative resection margins
- Nodal stage N0 to N3; resectable nodal disease with extranodal extension allowed at surgeon's discretion
- Eligible for curative intent treatment with likely negative surgical margins
- Examination under anesthesia for patients with questionable transoral access prior to randomization
- Blood work within 4 weeks before randomization showing adequate bone marrow, liver, and kidney function
- Assessment by both radiation oncologist and surgeon and presentation at multidisciplinary tumor board before randomization
You will not qualify if you...
- Serious medical conditions or contraindications to radiotherapy, chemotherapy, or surgery
- Prior head and neck cancer within the last 5 years
- Any prior radiation therapy to the head or neck
- Presence of metastatic disease
- Inability to complete full radiotherapy course or follow-up visits
- Prior invasive malignant disease unless disease-free for at least 5 years, excluding non-melanoma skin cancer
- Unable or unwilling to complete quality of life questionnaires
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9
Actively Recruiting
Research Team
S
Susan Archer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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