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

Not Applicable

Completed

• Conditions: Skin Basal Cell Carcinoma
• Interventions: Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT02579551
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-12-07
• Primary Completion: 2014-02-01
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Study Completion: 2017-05-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

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

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (surgical excision)	Therapeutic Conventional Surgery	Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.

Primary Outcome Measures

Name	Time	Method
Success rate for 1 mm margins	Up to 3 years	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.
Success rate for 2 mm margins	Up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate after 3 years	Up to 3 years

Trial Locations

Locations (1)

Thomas Jefferson Univeristy; 🇺🇸 Philadelphia, Pennsylvania, United States