RecruitingPhase 2

MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer

United States24 participantsStarted 2025-06-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Appropriate stage for study entry (T1-T3 N0 M0; AJCC 8th ed.) based on the following diagnostic workup: * 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. * Bilateral neck ultrasound within 60 days prior to registration * Risk Factors fitting either the High-Risk or Moderate-Risk Categories: * Risk Factor Definitions Major Risk Factors: Microscopic Extensive PNI (defined as PNI for \>3 nerves with all involved nerves either \>0.1 mm in size and/or deeper than the dermis), Gross PNI (defined as perineural spread evidenced on by MRI imaging, with cranial nerve deficit, or both), Size \>6 cm, or Recurrent disease status post prior Mohs Moderate-Risk Factors: Poor differentiation, 4-6 cm, PNI (defined as \>0.1 mm in size) BWH Risk factors: \>2 cm, poor differentiation, deep invasion, PNI (\>0.1 mm in size) • BWH: T2a = 1 risk factor; T2b = 2-3 risk factors, T3 = 4 risk factors High-Risk Group (Group H) Any 1 major OR 2-3 moderate OR BWH T3 Moderate-Ris…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exploring the Efficacy of Adjuvant Hypofractionated Radiation Therapy in High-Risk cSCC Head and Neck Patients: A Comparison of 2-Year Locoregional Recurrence Rates

Timeframe: 2 years

Trial details

NCT IDNCT06998342

SponsorUniversity of Vermont Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-04

Contact for this trial

Christopher Anker, MD

(802) 656-2021 chris.anker@uvmhealth.org

View on ClinicalTrials.gov More Cutaneous Squamous Cell Carcinoma (CSCC) trials