MOHs Surgery and Short-Course Radiation for Head & Neck Skin Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates two management strategies after Mohs surgery for head and neck cutaneous squamous cell carcinoma. High-risk patients receive a five-fraction, two-week short-course radiation therapy, while moderate-risk patients undergo active surveillance with regular exams and imaging. The study measures local, regional, and distant recurrence, treatment-related toxicity, and patient-reported quality of life over time. Outcomes will be compared to historical data for long-course radiation to understand relative effectiveness and safety. Optional blood sampling may provide exploratory biomarker data.

Why it matters

Who can join: the full rules

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-Risk Group (Group M) BWH T2b not meeting criteria for High-Risk.

Exclusion Criteria:

* 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.

Where it's running

• University of Vermont Medical Center
  Burlington, Vermont, United States Recruiting

Study contacts

• Study coordinator: Christopher Anker, MD
• Email: chris.anker@uvmhealth.org
• Phone: (802) 656-2021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.