Actively Recruiting
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Led by University of California, Irvine · Updated on 2026-05-05
111
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma to understand the effects of lowering the radiation dose in treatment. This observational registry study focuses on patients with clinical stage I, II, or III disease, excluding those with distant metastases. The goal is to evaluate how reducing radiation affects disease progression over a two-year period. Participants receive intensity-modulated radiation therapy (IMRT) given in 30 daily treatments of 2 Gy each, totaling 60 Gy, delivered six times per week starting on Day 1. High risk patients may also receive two cycles of chemotherapy with carboplatin and paclitaxel before radiation. The study monitors patients without randomization or comparison groups. During the study, participants will undergo assessments such as physical exams, weight checks, and PET/CT scans within six weeks before starting treatment. Researchers will monitor progression-free survival, overall survival, and local-regional control for up to two years from registration. This helps understand how well the reduced radiation dose controls the cancer and affects patient outcomes over time.
CONDITIONS
Brief Title
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed HPV-positive oropharyngeal squamous cell carcinoma defined by p16-positive tumors
- Clinical stage I, II, or III disease without distant metastases
- History and physical exam within 6 weeks before registration including weight assessment
- Age 18 years or older
- PET/CT scan within 6 weeks before registration
- Signed informed consent form
- Both men and women of all races and ethnic groups eligible
- Non-English speaking, deaf, hard of hearing, and illiterate individuals eligible
You will not qualify if you...
- Prior invasive cancer except non-melanomatous skin cancer unless disease-free for at least 3 years
- Previous surgeries other than diagnostic biopsy or nodal sampling for this cancer
- Prior systemic chemotherapy for this cancer
- Prior radiotherapy overlapping the proposed treatment area
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 weeks
Participants receive intensity-modulated radiation therapy (IMRT) given in 30 daily fractions at 2 Gy per fraction, six fractions per week. High risk participants may receive induction chemotherapy with 2 cycles of carboplatin and paclitaxel before radiation.
Daily visits for radiation treatment Monday through Saturday
Duration - Up to 2 years
Participants are monitored for progression-free survival, overall survival, and local-regional control for up to 2 years following treatment.
Follow-up visits as scheduled by the clinical team
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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