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

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.

Study Overview

• Status: Unknown
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Procedure: Low-Risk BCC Excisional Margins

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 Type: Interventional
• Enrollment (Anticipated): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • Advanced Aesthetics
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Dermatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Low-Risk BCC Excisional Margins; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Advanced Aesthetics
• Investigators: Principal Investigator: Jason B Lee, MD, Jefferson Dermatology Associates

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 19, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: IRB#11D.479

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No