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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01903239
• Other study ID #: IRB#11D.479
• Status: Active, not recruiting
• Phase: N/A
• First received: February 15, 2013
• Last updated: February 4, 2016
• Start date: November 2011
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

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.

Locations

Country	Name	City	State
United States	Advanced Aesthetics	Bensalem	Pennsylvania
United States	Jefferson Dermatology Associates	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Advanced Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC		3 years	No