Actively Recruiting
HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma
Led by University of Virginia · Updated on 2026-02-05
90
Participants Needed
5
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.
CONDITIONS
Official Title
HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and be available for the study duration
- Male or female, 18 years of age or older
- Pathologically confirmed squamous cell carcinoma of the oropharynx of any AJCC 8th edition stage
- Eligible for and planning to receive definitive or adjuvant radiotherapy treatment
- Concurrent systemic anticancer therapy allowed; chemotherapy required for T3-4 and/or N+ disease
- Participants with T1-2 and N0 disease may receive chemotherapy at physician's discretion
- Prior approval from Principal Investigator required for investigational agents
- ECOG Performance Status of 0 to 2
- p16 positive HPV confirmed by NavDx and immunohistochemistry
- Females of reproductive potential must agree to use adequate contraception during and for 6 months after radiation treatment
You will not qualify if you...
- Evidence of distant metastatic disease
- Prior radiotherapy to the head and/or neck
- Surgery for oropharyngeal cancer within 8 months unless incomplete oncologic surgery
- T3-4 and/or N+ disease without plans for concurrent chemotherapy
- Current or prior invasive malignancy except non-melanoma skin cancer if disease free less than 3 years
- Prisoner status
- Known contraindications to head and neck radiation such as ataxia telangiectasia or scleroderma
- Pregnancy or breastfeeding
- Active or severe co-morbidities including unstable angina, congestive heart failure, recent myocardial infarction, severe infections, respiratory illnesses, liver dysfunction, or AIDS
- Tobacco smoking history of 10 pack years or more, or 20 pack years if quit less than 1 year ago
- Current use of antineoplastic drugs for other cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
2
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
3
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Not Yet Recruiting
4
Bon Secours
Richmond, Virginia, United States, 23114
Not Yet Recruiting
5
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
Research Team
S
Song W
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here