RecruitingNot ApplicableNCT06554158

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

A Phase II Study of Post-Resection Radiation Dose and Treatment Site De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer

Sponsor

Georgetown University

Enrollment

30 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a reduced dose of adjuvant (post-surgery) radiation therapy is just as effective as standard-dose radiation for patients with low-risk, HPV-associated oropharyngeal cancer (cancer of the throat/tonsil area caused by HPV) who have already had surgery. Reducing radiation could decrease long-term side effects. **You may be eligible if...** - You are 18 or older with HPV-positive squamous cell cancer of the oropharynx (tonsil, base of tongue, or soft palate) - Your cancer is early-stage (Stage I or II) with limited lymph node involvement and clean surgical margins - You are a current non-smoker (smoke-free for at least 6 months) with limited smoking history (≤15 pack-years) - You had surgery via a minimally invasive oral approach (transoral surgery) with neck dissection **You may NOT be eligible if...** - Your tumor shows perineural invasion, lymphovascular invasion, or extensive spread to lymph nodes - You have had another cancer diagnosis in the past 2 years (with some exceptions) - Your surgery required a jaw-splitting or invasive non-oral approach Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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