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)
Medical University of South Carolina
36 participants
Oct 1, 2026
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
Plain Language Summary
Simplified for easier understanding
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
Active surveillance without postoperative radiation using routine clinical follow-up and serial ctHPVDNA testing to detect recurrence.
Locations(1)
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NCT07513389