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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Basal Cell Carcinoma
• Intervention / Treatment: Procedure: Therapeutic Conventional 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 Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Univeristy

Participation Criteria

Eligibility Criteria

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

Description

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 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
Experimental: Treatment (surgical excision); Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.	Procedure: Therapeutic Conventional Surgery; Undergo surgical excision

What is the study measuring?

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	Time Frame
Recurrence rate after 3 years	Up to 3 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Jason Lee, MD, Thomas Jefferson University

Publications and helpful links

Helpful Links

• Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): May 4, 2017

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

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: 11D.479; NCI-2015-01624 (Registry Identifier: NCI Trial Identification)