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

Skin Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579551
• Other study ID #: 11D.479
• Secondary ID: NCI-2015-01624
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: April 23, 2018
• Start date: December 7, 2011
• Est. completion date: May 4, 2017

Study information

• Verified date: April 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: May 4, 2017
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Skin Basal Cell Carcinoma

Intervention

Procedure:
• Therapeutic Conventional Surgery
Undergo surgical excision

Locations

Country	Name	City	State
United States	Thomas Jefferson Univeristy	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recurrence rate after 3 years		Up to 3 years

External Links

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