RecruitingPhase 2NCT07513389

Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)

Omission of Immediate Postoperative Radiation in Patients With Intermediate Pathological Risk Features and Negative Two-Week Post-Operative ctHPVDNA (OPERATION Trial)


Sponsor

Medical University of South Carolina

Enrollment

36 participants

Start Date

Oct 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This single-arm Phase II trial evaluates whether omission of postoperative radiotherapy is feasible and oncologically safe in select patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). Eligible patients undergo transoral robotic surgery (TORS) and are observed without adjuvant radiation if they demonstrate low or intermediate pathological risk features and have negative circulating tumor HPV DNA (ctHPVDNA) two weeks post-operatively. Patients are followed with standard clinical surveillance combined with serial ctHPVDNA testing (NavDx®) to facilitate early detection of recurrence and prompt salvage therapy as needed.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Active Surveillance With ctHPVDNA (NavDx®) for people with human papilloma virus (hpv), oropharyngeal squamous cell carcinoma (opscc), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERActive Surveillance With ctHPVDNA (NavDx®)

Active surveillance without postoperative radiation using routine clinical follow-up and serial ctHPVDNA testing to detect recurrence.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07513389


Related Trials