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

Primary Purpose

Skin Basal Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Conventional Surgery
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Basal Cell Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Thomas Jefferson Univeristy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (surgical excision)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Recurrence rate after 3 years

Full Information

First Posted
October 12, 2015
Last Updated
April 23, 2018
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02579551
Brief Title
Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery
Official Title
Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 7, 2011 (Actual)
Primary Completion Date
February 1, 2014 (Actual)
Study Completion Date
May 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (surgical excision)
Arm Type
Experimental
Arm Description
Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo surgical excision
Primary Outcome Measure Information:
Title
Success rate for 1 mm margins
Description
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.
Time Frame
Up to 3 years
Title
Success rate for 2 mm margins
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Recurrence rate after 3 years
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Lee, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson Univeristy
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

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

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