MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck
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 que
| Condition(s) | Cutaneous Squamous Cell Carcinoma (CSCC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 rec |
| Who can participate | 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-Ris |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Vermont Medical Center |
| Locations | Burlington, Vermont, United States |
| Start date | 2025-06-04 |
| NCT ID | NCT06998342 |
| Official listing | https://clinicaltrials.gov/study/NCT06998342 |