Actively Recruiting
De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
Led by Georgetown University · Updated on 2026-03-23
30
Participants Needed
1
Research Sites
491 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
The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV/p16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are: Does radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields? Participants will: Undergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)
CONDITIONS
Official 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 of age or older at consent.
- Diagnosed with p16-positive and/or HPV-positive squamous cell carcinoma of the oropharynx.
- Pathologic stage T1-2 N1 M0 (stage I) or T3 N0-1 M0 (stage II) with no more than 5 lymph nodes involved and extracapsular extension of 2mm or less.
- Surgical margins of at least 2mm at the primary site.
- 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; transfusions allowed to meet this.
- Non-smoker for at least 6 months with a smoking history of 15 pack-years or less.
- Radiation treatment to start within 8 weeks after surgery, preferably within 6 weeks.
- Must have had Transoral Surgery and neck dissection on at least the same side of the neck.
- Women of child-bearing potential and men must agree to use adequate contraception before and during the study and for 90 days after treatment.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Presence of perineural invasion at the primary tumor site.
- Presence of lymphovascular space invasion at the primary tumor site.
- Involvement of level 4 lymph nodes.
- Retropharyngeal lymph node involvement.
- Any remaining unresected disease.
- Nodal disease invading adjacent neck muscles.
- Prior invasive surgery to the primary site not done through the mouth (e.g., mandibulotomy or lateral pharyngotomy).
- History of other cancers within 2 years before enrollment except treated nonmelanoma skin cancer or low-risk prostate cancer under surveillance.
- Extracapsular extension without confirmed biopsy of the affected lymph node.
AI-Screening
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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
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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