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.
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, ≥ 18 years of age (no upper age limit).
Biopsy proven squamous cell carcinoma.
Prior history of surgery to the head and neck that in the opinion of the investigators would modify prognostic significance of pathology results.
Prior history of radiation therapy to the head and neck, with the exception of skin cancer treated with a small (≤ 9cm3) field with 6 - 9 MeV electron beam or 50 - 250 kVp photon beam.
Basal cell carcinoma of the skin
Squamous cell carcinoma of the skin, stage 1-2
Single group
Active Surveillance With ctHPVDNA (NavDx®)
Other interventionActive surveillance without postoperative radiation using routine clinical follow-up and serial ctHPVDNA testing to detect recurrence.
Local-Regional Control
Proportion of participants without local or regional recurrence above the clavicles at 2 years following definitive surgery, including participants who recur but are successfully salvaged with radiation or chemotherapy during the 2-year postoperative period.
Progression-Free Survival (PFS)
Time from surgery to disease progression or death from any cause.
Distant Metastasis-Free Survival (DMFS)
Time from surgery to development of distant metastatic disease or death.
Overall Survival (OS)
Time from surgery to death from any cause.
Swallowing Function (Functional Oral Intake Scale - FOIS)
Change in swallowing function measured using the Functional Oral Intake Scale (FOIS).
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