Actively Recruiting
Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.
Led by University of Utah · Updated on 2026-02-27
42
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.
CONDITIONS
Official Title
Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant aged 60; 18 years.
- Diagnosis of oropharyngeal squamous cell carcinoma.
- Eligible to receive trans-oral robotic surgery.
- Known p16 positivity or HPV positivity by in situ hybridization on tumor or lymph node samples, or HPV/p16 status to be determined before step-2 registration.
- Pre-operative TTMV-HPV DNA test collected or planned before surgery.
- ECOG Performance Status 64; 2.
- Able to provide informed consent.
- Completion of trans-oral robotic surgery (for step 2 registration).
- Pre- and post-operative TTMV-HPV DNA test results obtained (for step 2 registration).
- For participants of childbearing potential: negative pregnancy test or permanent sterilization and agreement to use highly effective contraception.
- Post-menopausal status defined by institution criteria based on age and hormone levels (for participants C 50 years or 60; 50 years).
You will not qualify if you...
- History of prior mucosal head and neck cancer treated with radiation therapy.
- Prior or concurrent malignancy interfering with safety or efficacy assessment.
- Smoked cigarettes within 1 month of registration.
- Prior systemic anti-cancer or investigational therapy within 14 days or five half-lives before study treatment.
- Known distant metastatic disease.
- Medical conditions contraindicating participation due to safety or compliance concerns (e.g., infection, intestinal obstruction, inability to swallow medication, social or psychological issues).
- Medical, psychiatric, cognitive, or other conditions compromising ability to consent, comply, or complete the study.
- For step 2, low-risk disease criteria including specific tumor stages, lymph node involvement, smoking history, and surgical pathology findings.
- For step 2 exploratory arm, pre-operative TTMV-HPV DNA score greater than 50 or contraindicating conditions as above.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingford
CONTACT
S
Shane Lloyd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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