Actively Recruiting
Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma
Led by University of Florida · Updated on 2026-04-24
250
Participants Needed
3
Research Sites
524 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
Naveris, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).
CONDITIONS
Official Title
Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with no upper age limit
- T0-3, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging
- Tissue diagnosis positive for HPV and/or p16 from the primary site or lymph node
- Radiologic confirmation of no lung metastasis within 12 weeks before treatment (CT chest required, PET-CT acceptable)
- ECOG Performance Status between 0 and 2
- Smoking history of 10 pack-years or less, or no smoking for at least 10 years
- Eligible for chemotherapy treatment
- Adequate bone marrow function with platelets ≥ 100,000 cells/mm3 and hemoglobin ≥ 8.0 g/dl
- Adequate kidney and liver function within 12 weeks before treatment (creatinine < 2.0 mg/dl, bilirubin < 2 times upper limit, AST/ALT < 3 times upper limit)
- Negative pregnancy test within 3 weeks before treatment for women who can become pregnant
- Use of effective contraception during study and for 14 months after last treatment for people of childbearing potential
- Agreement to use contraception for partners of childbearing potential during study and for 14 months after last treatment
- Provided informed consent specific to this study
You will not qualify if you...
- Prior radiotherapy for oropharyngeal squamous cell carcinoma or head and neck that may harm critical organs
- Prior cancer within the last 10 years, except resolved or indolent non-oropharynx cancers as judged by physician
- Prior surgery with curative intent for this OPSCC
- No gross cancer present at start of radiation therapy if tonsillectomy or neck node biopsy was done
- Smoking tobacco inhalation within the last 10 years with more than 10 pack-year history
- Current use of Disease Modifying Rheumatoid Drugs or immunosuppressive medication
- Severe active co-morbidities such as recent unstable angina, heart failure, heart attack, serious infections, respiratory illnesses, liver failure, active autoimmune diseases, or psoriatic arthritis
- Known HIV positive status
- People of childbearing potential unwilling or unable to use contraception for study duration plus 14 months
- Pregnancy or breastfeeding
- Prisoners or involuntarily incarcerated or detained for psychiatric or physical illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
2
UF Health Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Actively Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
T
Teresa Ware, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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