MOHs Surgery and Adjuvant Short-course Hypofractionated Radiation Therapy With Structured Surveillance for Cutaneous Head & Neck Squamous Cell Carcinoma: a Phase II Pilot Study (MOHSAHRTSS-Study)
University of Vermont Medical Center
Summary
The goal of this clinical trial is to evaluate if short-course radiation therapy (SCRT) can effectively treat high-risk cutaneous squamous cell carcinoma (cSCC) and if active surveillance is a safe alternative to radiation for moderate-risk cSCC in adults with head and neck cSCC who have undergone surgery. The main questions it aims to answer are: Does short-course radiation therapy (5 treatments over 2 weeks) effectively prevent cancer recurrence in high-risk patients? Can moderate-risk patients be safely monitored with active surveillance instead of receiving radiation? Researchers will compare: Short-course radiation therapy (SCRT) for high-risk patients to historical data on long-course radiation to determine effectiveness. Active surveillance for moderate-risk patients to expected recurrence rates to assess safety. Participants will: High-Risk Group (SCRT): Receive short-course radiation therapy and attend follow-up visits. Moderate-Risk Group (Active Surveillance): Have regular check-ups, including clinical exams and imaging, to monitor for cancer recurrence. Optionally provide blood samples for future biomarker research.
Description
This clinical trial investigates two approaches for managing cutaneous squamous cell carcinoma (cSCC) of the head and neck following surgical resection, based on patient risk stratification. The study evaluates short-course radiation therapy (SCRT) as a treatment for high-risk cSCC and active surveillance as a potential alternative to radiation therapy for moderate-risk cSCC. High-Risk Cohort (Short-Course Radiation Therapy - SCRT) Patients classified as high risk will undergo SCRT, consisting of five fractions of radiation therapy over a two-week period. This approach aims to provide effecti…