Actively Recruiting
Post-Surgery Radiation Dose and Site De-Escalation for Favorable Prognosis HPV or p16-Positive Oropharyngeal Cancer
Led by Georgetown University · Updated on 2026-03-23
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
M
MedStar Georgetown University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether patients with intermediate-risk HPV or p16 positive oropharyngeal cancer, who have had Transoral Robotic Surgery and minimal smoking history, can safely receive a lower radiation dose targeted only to the neck instead of the original tumor site. The study aims to see if reducing radiation dose and limiting the treatment area leads to similar tumor control compared to standard radiation therapy. This approach may improve quality of life by reducing treatment side effects. Participants will receive a lower than standard radiation dose of 50 Gy in 25 fractions using either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy. The radiation will be focused solely on the neck, excluding the primary tumor site in the oropharynx. This de-escalation approach contrasts with the usual 60 Gy dose to both the primary site and neck. The study is a phase II trial and builds on previous research showing success with dose reduction and omission of chemotherapy in similar patients. During the study, participants will be closely monitored through various assessments including tumor progression, quality of life measures, and survival outcomes over two years. Researchers will track progression-free survival as the primary outcome along with local and regional cancer control, distant metastasis-free survival, overall survival, and the rate of feeding tube placement. Study visits include clinical evaluations, imaging, and laboratory tests. Participation may last for several years with ongoing follow-up to evaluate long-term effects and safety.
CONDITIONS
Brief Title
De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older on the day of signing consent
- Diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx
- Pathologic stage T1-2 N1 M0 stage I or T3 N0-1 M0 stage II with up to 5 involved lymph nodes and 4 mm extracapsular extension
- Surgical margins at primary site of at least 2 mm
- Karnofsky Performance Status of 60 or higher within 8 weeks before registration
- Neutrophil to lymphocyte ratio of 5 or less within 8 weeks before registration
- Hemoglobin count of 10 or higher within 8 weeks before registration (transfusion allowed)
- Non-smoker for at least 6 months with 15 pack-year smoking history or less
- Radiation treatment to start within 8 weeks after surgery
- Have had resection of primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck
- Women of child-bearing potential and men must agree to use birth control during and 90 days after the study
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of perineural invasion at primary site
- Presence of lymphovascular space invasion at primary site
- Level 4 lymph node involvement
- Retropharyngeal lymph node involvement
- Any remaining unresected disease
- Nodal disease invading nearby neck muscles
- Prior invasive non-oral surgery to primary site (e.g., jaw-splitting or lateral pharyngotomy)
- Cancer diagnosed within 2 years before registration except treated nonmelanoma skin cancer or low-risk prostate cancer under surveillance
- Patients with extracapsular extension who have not had biopsy confirming squamous cell carcinoma in an ipsilateral neck lymph node
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 adjuvant radiation therapy with a lower than standard radiation dose (50Gy in 25 fractions) directed to the neck at risk for tumor recurrence, excluding the primary tumor site.
Daily visits for radiation therapy sessions during treatment period
Duration - Up to 2 years
Participants are monitored for treatment outcomes including cancer control, survival, and quality of life after completing radiation therapy.
Regular visits scheduled over 2 years for outcome assessments
Trial Site Locations
Total: 1 location
1
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
Research Team
P
Peter Ahn, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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