Study of Surgery Without Immediate Radiation for Select Patients With HPV-Related Oropharyngeal Cancer and Negative Post-Surgery HPV DNA Test

What this Trial Is About

Researchers are evaluating whether it is possible and safe to skip postoperative radiation in selected patients with HPV-associated oropharyngeal squamous cell carcinoma HPV-OPSCC. This Phase II trial focuses on patients who undergo transoral robotic surgery TORS and have low or intermediate pathological risk, as well as negative circulating tumor HPV DNA ctHPVDNA two weeks after surgery. The study aims to monitor these patients closely to detect any recurrence early and provide prompt treatment if needed. Participants receive active surveillance without additional radiation after surgery. They are observed through routine clinical follow-up combined with serial ctHPVDNA testing using the NavDx method to detect any signs of cancer returning. This approach applies only to patients who meet the specific risk and molecular criteria post-surgery, with no adjuvant radiation given if ctHPVDNA is negative. During the study, participants undergo standard clinical surveillance and regular blood tests for ctHPVDNA over several years to identify potential recurrence early. The main outcome measured is local-regional control two years after surgery. Researchers also track progression-free survival, distant metastasis-free survival, overall survival, swallowing function, and symptoms up to five years post-surgery. Participants are followed for up to five years with ongoing assessments to ensure safety and effectiveness of this radiation omission strategy.

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