Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas

N/AUnknownNCT01903239

Thomas Jefferson University179 enrolled

Overview

The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are evaluated.

Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

179

Conditions

Basal Cell Carcinoma

Interventions

Low-Risk BCC Excisional MarginsPROCEDURE

After the head and neck basal cell carcinomas satisfy the National Comprehensive clinical and histopathological criteria, all tumors are excised at the 2 mm margin.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has a BCC \<10mm on their cheeks, forehead, scalp \& neck or \<6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear * The BCC has well defined borders * The BCC is primary * The Patient is not immunosuppressed * The BCC is not located at a site of prior radiation therapy * The histologic subtype is nodular or superficial * There is no perineural involvement Exclusion Criteria: * Patient has a BCC \>or=10mm on their cheeks, forehead, scalp \& neck or \>or=6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear * The BCC has poorly defined borders * The BCC is recurrent * The Patient is immunosuppressed * The BCC is located at a site of prior radiation therapy * The histologic subtype is aggressive * There is perineural involvement

Locations (2)

Advanced Aesthetics

Bensalem, Pennsylvania, United States

Jefferson Dermatology Associates

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC

Time frame: 3 years

Data from ClinicalTrials.gov

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