Actively Recruiting
Circulating Tumor Modified HPV DNA-Guided Radiotherapy De-intensification of the Elective Neck (RaDEN) in Squamous Cell Carcinoma of the Head and Neck
Led by University of Virginia · Updated on 2026-02-05
90
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of lower doses of radiation therapy for treating head and neck squamous cell carcinomas, specifically HPV-positive oropharyngeal squamous cell cancers. This study aims to see if reducing the radiation dose can prevent cancer recurrence while causing fewer side effects compared to standard radiation treatments. It is a phase 2 trial sponsored by the University of Virginia. Participants will receive a reduced radiation dose regimen with variations depending on whether they receive concurrent chemotherapy and their response to treatment as measured by a specialized blood test called NavDx. The radiation dose and volume are decreased compared to standard care, and those who respond slowly to treatment may get an additional radiation boost. Treatment includes 24 Gy in 12 fractions to the main tumor and intermediate lymph nodes, followed by either 30 or 36 Gy to the entire volume, with possible extra doses for non-rapid responders. Throughout the study, participants will undergo routine NavDx testing to monitor treatment response and detect cancer recurrence. They will also complete surveys about their overall health and quality of life. The primary outcome is disease control assessed up to two years after radiation. Safety and quality of life will be evaluated at intervals up to one and two years after treatment, respectively. The study involves non-randomized assignment and does not use masking.
CONDITIONS
Brief 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
- 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
- Receiving concurrent systemic anticancer therapy if T3-4 and/or N+ disease; chemotherapy optional for T1-2 and N0 disease
- May receive investigational agents with prior approval
- ECOG Performance Status of 0-2
- HPV positive (p16) by NavDx and immunohistochemistry
- For females of reproductive potential: agree to use contraception during radiation and for 6 months after
You will not qualify if you...
- Evidence of distant metastatic disease
- Prior radiotherapy to head and/or neck
- Surgery for oropharyngeal cancer within 8 months unless incomplete tumor removal
- T3-4 and/or N+ disease without concurrent chemotherapy planned
- Current or prior invasive malignancy unless disease free for at least 3 years (except non-melanoma skin cancer)
- Prisoner status
- Contraindications to head and neck radiation such as ataxia telangiectasia or scleroderma
- Pregnancy or lactation
- Active or severe co-morbidities including unstable angina, recent heart attack, severe infections, respiratory illness, severe 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 malignancies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 7 weeks depending on treatment regimen
Participants receive a reduced dose radiotherapy regimen to the head and neck, with dosing guided by blood tests, physical exams, and imaging. Some may receive concurrent chemotherapy and additional radiation boosts depending on treatment response.
Daily visits for radiation therapy sessions over several weeks with periodic blood tests and examinations
Duration - Up to 2 years after radiotherapy
Participants are monitored for disease control, safety, and quality of life after completing radiotherapy, including regular blood tests and surveys about overall health and wellbeing.
Regular follow-up visits over 2 years including blood tests and health surveys
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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