De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06554158
Status
Recruiting
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Conditions

  • Oropharynx Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Radiation Therapy — RADIATION
    De-escalation of Adjuvant Radiotherapy

Study Details

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)

Key Dates

Start date
Aug 1, 2019
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation dose: 50Gy
    50Gy in 25 fractions to the neck at risk for tumor recurrence, excluding the primary site

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 2 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007
Peter Ahn, MD
[email protected]
202-444-4036
Peter Ahn, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Medstar Georgetown University Hospital· Washington D.C., DC

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