The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma is an interventional trial currently recruiting patients with early to intermediate stage HPVOPC.
People with HPVOPC are generally curable, are young, and will live for extended periods of time, and are also at high risk for long-term toxicity and morbidity from chemotherapy and radiation. The study will explore the necessity of additional intervention in HPVOPC after surgery, and it is estimated that more than half of patients will not require additional therapy.
The trial will have three study groups. Patients with a good prognosis at low risk of recurrence will undergo surgery but no radiotherapy or chemoradiotherapy. Patients at intermediate risk of recurrence will undergo surgery and receive radiotherapy, and patients at high risk of recurrence will undergo surgery and receive chemoradiotherapy.
Patients are eligible for the study if they have stage 1, 2, 3, or early- to mid-stage 4a resectable primary squamous cell carcinoma of the oropharynx that is HPV positive. Patients must be at least 18; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an ECOG performance status of 0 or 1; have a limiting serious illness; and have had no previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Second study outcome measures include overall survival, toxicity rates, and quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov .