De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers
NCT06554158 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-03-23
Summary
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
- Oropharynx Cancer
Interventions
- RADIATION
-
Radiation Therapy
De-escalation of Adjuvant Radiotherapy
Sponsors & Collaborators
-
MedStar Georgetown University Hospital
collaborator OTHER -
Georgetown University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-08-01
- Primary Completion
- 2026-12-31
- Completion
- 2028-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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