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

University of Pittsburgh

Status: Terminated

Conditions: High Risk Cutaneous Squamous Cell Carcinoma

Treatments: Procedure: elective lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT01252329

PRO10030462

Details and patient eligibility

About

This study will evaluate if there is a difference in survival between elective treatment of draining lymph nodes vs. clinical nodal observation in patients undergoing Mohs surgery for high risk skin squamous cell carcinoma of the head and neck who have a normal lymph node exam. Each treatment arm is accepted as a current standard of care, and the objective is to compare outcomes between the two arms.

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Elective lymph node treatment arm

Active Comparator group

Description:

Patients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated.

Treatment:

Procedure: elective lymph node dissection

Clinical observation arm

No Intervention group

Description:

Patients who enter into this arm will undergo regular, periodic clinical nodal observation with subsequent evaluation and treatment if indicated upon discovery of a palpable lymph node.