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.
Pathologically confirmed cutaneous squamous cell carcinoma of the head & neck region, defined as extending from vertex of head to supraclavicular region.
Mohs micrographic surgery with or without further surgery following Mohs to achieve negative margins (i.e. R0 margin status) within 70 days prior to registration
Clinical exam within 60 days prior to registration
CT head & neck/soft tissue with IV contrast within 60 days prior to registration or MR face and neck with IV contrast. IV contrast may be held if medically contraindicated.
Patients receiving any other investigational agents.
Parallel
Short course radiation
RadiationThe radiation arm in this study involves Short Course Radiation Therapy (SCRT), which consists of 5 fractions delivered twice a week (either Monday/Thursday or Tuesday/Friday).
Active Surveillance
Other interventionThe Active Surveillance arm (Group M) aims to monitor participants with moderate-risk cutaneous squamous cell carcinoma (cSCC) after surgical resection, without immediate intervention unless disease progression occurs. Participants will undergo regular clinical evaluations, physical exams, and skin checks to detect new lesions or signs of recurrence. Imaging, including ultrasound and CT/MRI scans, will be performed every 6 months for up to 3 years to monitor for metastasis or progression. Blood samples will be collected for future biomarker analysis to identify indicators of disease recurrence. Participants will also complete quality of life assessments using the EORTC QLQ-C30 and Skin Cancer Index (SCI) to evaluate the impact of surveillance on their daily lives. If disease progression is detected, radiation therapy may be initiated. The study will track overall survival without initiating radiation, as well as disease progression and quality of life outcomes, to determine if active s
Exploring the Efficacy of Adjuvant Hypofractionated Radiation Therapy in High-Risk cSCC Head and Neck Patients: A Comparison of 2-Year Locoregional Recurrence Rates
To explore the potential efficacy of adjuvant hypofractionated radiation therapy (SCRT) in high-risk cutaneous squamous cell carcinoma (cSCC) head and neck patients by examining the 2-year locoregional recurrence rate (LRR) and comparing it to historical controls who received standard long-course radiation therapy (LCRT). Considering the variability in LRR among patients eligible for SCRT, the researchers aim to investigate whether a 2-year LRR \<25% could be achieved.
2-Year Locoregional Recurrence Rate (LRR) in Moderate-Risk SCC Patients
To assess the 2-year rate of locoregional recurrence (LRR) in moderate-risk patients undergoing active surveillance, compared to historical controls. Unit of Measure: Percentage of participants with locoregional recurrence.
2-Year Overall Survival (OS) in High-Risk SCC Patients Receiving SCRT
To evaluate overall survival at 2 years in high-risk patients treated with short-course radiation therapy (SCRT), compared to historical controls who received long-course radiation therapy (LCRT). Unit of Measure: Percentage of participants alive at 2 years.
Health-Related Quality of Life (HRQoL) in High-Risk SCC Patients as Measured by EORTC QLQ-C30
To assess overall health-related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in patients receiving SCRT or active surveillance. This validated questionnaire includes subscales for physical, emotional, and social functioning, among others. Unit of Measure: Score on scale from 0 to 100; higher scores on functioning scales and global health indicate better outcomes; higher scores on symptom scales indicate worse symptoms.
2-Year Overall Survival (OS) in Moderate-Risk SCC Patients
To assess overall survival (OS) at 2 years in moderate-risk patients undergoing active surveillance. OS is defined as time from surgery to death from any cause. Unit of Measure: Percentage of participants alive at 2 years.
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