RecruitingNot ApplicableNCT06915038

ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx

Sponsor

Indiana University

Enrollment

120 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Throat Cancer Squamous Cell Carcinoma of Oropharynx HPV Positive Cancer Tonsil Cancer

Summary

This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a blood test that detects HPV DNA can help guide treatment decisions for patients with HPV-related throat cancer (oropharyngeal cancer). Researchers are tracking HPV DNA levels before and after surgery to better understand how well treatment is working. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the throat (oropharynx) that is HPV-positive - Your cancer has been confirmed as resectable (surgically removable) with a high chance of clear margins - Your tumor stage is T1, T2, or select T3 that does not invade the larynx - Your neck node stage is N0, N1, or N2 - A detectable HPV DNA level was found in your blood before treatment **You may NOT be eligible if...** - You have cancer that has spread to distant parts of your body - You have had previous head and neck radiation or another head and neck cancer within the last 3 years - You have a serious medical condition that prevents surgery under general anesthesia - You have another HPV-positive throat cancer at the same time 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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Interventions

DIAGNOSTIC_TESTNavDx

NavDx is a clinically validated blood test to detect circulating tumor HPV DNA (ctHPVDNA). In this study, ctHPVDNA results, in conjuction with specimen analysis, will be used to assign post-surgical adjuvant treatment.

RADIATIONAdjuvant Radiation 30 Gray

If undetectable postoperative ctHPVDNA levels and five or more positive nodes, or confirmed extranodal extension (ENE) (greater than 2 mm) deintensified radiation treatment of 30 gray.

RADIATIONAdjuvant Radiation 40 Gray

If detectable postoperative ctHPVDNA, then reimage to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation if N0 or N1 disease, and 30 Gy of radiation if N2 disease on final pathologic staging. If repeat ctHPVDNA level is positive, or shows no obvious operable disease, then subject will undergo 40 Gy of radiation.