Status:
NOT_YET_RECRUITING
MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer
Lead Sponsor:
University of Vermont Medical Center
Conditions:
Cutaneous Squamous Cell Carcinoma (CSCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 al...
Detailed 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...
Eligibility Criteria
Inclusion
- 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-Risk Group (Group M) BWH T2b not meeting criteria for High-Risk.
Exclusion
- Patients receiving any other investigational agents.
- Patients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Serious medical comorbidities that, in the opinion of the radiation oncologist, would prevent participation in this study.
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2031
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06998342
Start Date
June 1 2025
End Date
May 1 2031
Last Update
May 31 2025
Active Locations (1)
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1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401