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

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.

NCT Number	NCT07513389
Lead Sponsor	Medical University of South Carolina
Conditions	Squamous Cell Carcinoma, Human Papilloma Virus (HPV), Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Enrollment	36 participants
Start Date	2026-10-01
Primary Completion	2029-07-01 (estimated)
Study Completion	2030-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-30