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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-07

Study Completion Date

2017-05-04

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.

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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.

Conditions

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Skin Basal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (surgical excision)

Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.

Group Type EXPERIMENTAL

Therapeutic Conventional Surgery

Intervention Type PROCEDURE

Undergo surgical excision

Interventions

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Therapeutic Conventional Surgery

Undergo surgical excision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Location

1. Area M (cheeks, forehead, scalp \& neck) tumor size \< 10 mm
2. Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear) tumor size \< 6 mm
2. Well-defined borders
3. Primary BCC
4. Patient is not immunosuppressed
5. There has not been prior radiotherapy to the site
6. Nodular subtype
7. No perineural involvement-(no neurological deficits grossly) -

Exclusion Criteria

1. Location

1. Area M tumor size \> or = to 10 mm
2. Area H tumor size \> or = to 6 mm
2. Poorly defined borders
3. Recurrent BCC
4. Patient is immunosuppressed
5. There has been prior radiotherapy to the site -

Eligible Sex

ALL

Accepts Healthy Volunteers

No