HYHOPE: Phase I study of de-intensified hypofractionated radiation therapy for human papilloma virus-associated oropharynx cancer

Summary: 

The incidence of Human Papilloma Virus-associated oropharyngeal squamous cell carcinoma is increasing in the United States accounting for 70-80% of newly diagnosed oropharyngeal cancers. Standard of care radiation therapy using conventional methods for oropharyngeal squamous cell carcinoma takes seven weeks to complete, making it one of the longest radiation therapy courses among all cancers. There is an interest in seeing if similar outcomes can be achieved with a reduced number of sessions, thus improving the cost-effectiveness. In other cancers such as breast and prostate, hypofractionated radiation therapy is used and has been shown to have similar outcomes and a similar side effect profile. Hypofractionated radiation therapy is when larger doses of radiation (>2 Gy) are given each session and it is given over a shorter period of time than standard radiation therapy. This phase I study will assess the tolerability of de-intensified hypofractionated radiation therapy given over the course of 3 weeks. The total cumulative dose of radiation will be lower with the potential to significantly decrease the side effects of radiation therapy compared to standard of care. Also, given that it is delivered over three weeks versus seven weeks, the cost and burden of treatment will be decreased.

Trial Registration: ClinicalTrials.gov Identifier: NCT04580446