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

Not Applicable

• Conditions: Basal Cell Carcinoma
• Interventions: Procedure: Low-Risk BCC Excisional Margins

• Registration Number: NCT01903239
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-Risk BCC Excisional Margins	Low-Risk BCC Excisional Margins	This is a study investigating the efficiency of 1-2 mm margins for the excision of low-risk basal cell carcinoma.

Primary Outcome Measures

Name	Time	Method
Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC	3 years

Trial Locations

Locations (2)

Advanced Aesthetics; 🇺🇸 Bensalem, Pennsylvania, United States

Jefferson Dermatology Associates; 🇺🇸 Philadelphia, Pennsylvania, United States