Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery

Study Overview
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Brief Summary
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This clinical trial studies the effectiveness of narrow margins in patients with low-risk basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the area of normal tissue around a tumor taken out during surgery to make sure all of the cancer is removed. This clinical trial studies tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate. This may allow less normal tissue to be removed from patients and may be a less expensive surgery.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the success rate of narrow margin excisions of low-risk facial basal cell carcinoma (BCC). SECONDARY OBJECTIVES: I. To determine the narrowest excision margin for low-risk facial BCC that gives an acceptable (95%) cure rate over a 3 year follow-up period.

Official Title
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Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas

Conditions
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Skin Basal Cell Carcinoma

Intervention / Treatment
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* Procedure: Therapeutic Conventional Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Location Area M (cheeks, forehead, scalp & neck) tumor size < 10 mm Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear) tumor size < 6 mm Well-defined borders Primary BCC Patient is not immunosuppressed There has not been prior radiotherapy to the site Nodular subtype No perineural involvement-(no neurological deficits grossly) - Exclusion Criteria: Location Area M tumor size > or = to 10 mm Area H tumor size > or = to 6 mm Poorly defined borders Recurrent BCC Patient is immunosuppressed There has been prior radiotherapy to the site -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (surgical excision)<br>Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1. | Procedure: Therapeutic Conventional Surgery<br>* Undergo surgical excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate for 1 mm margins | The success rate for 1 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion. | Up to 3 years | 
| Success rate for 2 mm margins | The success rate for 2 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate after 3 years |  | Up to 3 years |