Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)

This is a prospective, randomized, non-blinded, controlled trial of high risk head and neck
cutaneous squamous cell carcinomas which will compare specific outcomes between two treatment
arms. Subjects are eligible patients who are sent to Zitelli & Brodland PC for Mohs
micrographic surgery of tumors that meet our high risk criteria. These patients with
clinically-negative lymph node exams will either enter into the arm of nodal observation or
the arm of elective management of the neck, which is currently the standard protocol per the
UPMC ENT department. The patients in the observation arm will have evaluation and treatment
of their lymph nodes if an abnormality is detected clinically. The primary endpoint is
disease-specific survival. Secondary endpoints will include overall and disease-free
survival, complications, and quality of life measures for each arm.

Inclusion Criteria: Major criterion and at least one minor criteria

- Major criterion: > 6 mm depth of invasion

- Minor criteria (one or more):

- Greater than 2cm diameter

- Recurrent (prior Mohs, wide local excision, electrodesiccation and curettage, topical
imiquimod or 5 fluorouracil, cryotherapy or photodynamic therapy)

- High risk location: any portion of cutaneous lip, ear, temple, scalp

- Immunosuppressed host (organ transplant recipient or chronic lymphocytic leukemia)

- Perineural invasion (yes/no; nerve involved must be greater than 0.1mm)

- Direct involvement of subcutaneous tissue (Clark's V), muscle, cartilage,or bone

Exclusion Criteria:

- Satellite metastases

- Clinically abnormal lymph node exam

- Location other than head or neck

- Exclusively mucosal squamous cell carcinoma

- Previous head and neck radiation

- In situ disease, keratoacanthoma subtypes, metatypical or collision tumors

- Inability of subject to give written informed consent

- Pregnancy