Randomized Clinical Trial of Tele-Surveillance and Remote Symptom Monitoring Compared to Standard Surveillance for HPV-Associated Oropharynx Cancer with No Evidence of Disease on Post-Treatment Imaging.

The incidence of Human Papilloma Virus (HPV) associated oropharyngeal cancer has risen rapidly over the past two decades with excellent prognosis and high rates of locoregional control. Post-treatment PET/CT for oropharyngeal cancer has a very high negative predictive value. Despite the improved outcomes for HPV-associated oropharyngeal cancer and the predictive value of post-treatment PET/CT, national guidelines for post-treatment surveillance of oropharyngeal cancer do not distinguish according to HPV status. The benefits and costs of various post-treatment surveillance regimens for patients with no evidence of disease on post-treatment PET/CT are unknown. Telemedicine with remote patient monitoring is a novel strategy to surveil patients while reducing the burden of traditional follow up regimens. This randomized clinical trial will test the hypothesis that tele-surveillance is non-inferior to standard surveillance for detection of progression-free survival (PFS) events (NCT05048459). Eligible patients have a diagnosis of HPV associated squamous cell carcinoma of the oropharynx with no evidence of disease on PET/CT imaging within 9 months of completing radiation therapy. No evidence of disease is a multi-disciplinary consensus determination by the patient's radiation, medical, and surgical oncologist. Patients are randomized 1:1 between standard surveillance according to institutional and national guidelines vs tele-surveillance with remote patient monitoring. Patients in the tele-surveillance arm have an annual tele-visit and remote patient monitoring every 6 months. All patients will complete the EORTC QLQ-C30, EORTC QLQ-HN43, and COST: A FACIT questionnaires annually as well as blood collection every 6 months for circulating tumor HPV DNA. The primary endpoint is 2-year PFS with a noninferiority margin of 12% for tele-surveillance. Sixty patients will be randomized between arms. Secondary endpoints include patient reported global and head and neck specific quality of life, locoregional control, distant metastases, overall survival, patient reported financial toxicity, cost of surveillance approach, physician and patient satisfaction, and detection of recurrence with circulating tumor HPV DNA. TBD TBD [ABSTRACT FROM AUTHOR]