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

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02579551
• Collaborator: (none)
• Enrollment: 179
• Location: 1
• Arm: 1
• Actual Duration (Months): 64.9
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Basal Cell Carcinoma	Procedure: Therapeutic Conventional Surgery	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. To determine the success rate of narrow margin excisions of low-risk facial basal cell carcinoma (BCC).

SECONDARY OBJECTIVES:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 179 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas
• Actual Study Start Date: Dec 7, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: May 4, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. Recurrence rate after 3 years [Up to 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Location

2. Area M (cheeks, forehead, scalp & neck) tumor size < 10 mm

3. Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear) tumor size < 6 mm

4. Well-defined borders

5. Primary BCC

6. Patient is not immunosuppressed

7. There has not been prior radiotherapy to the site

8. Nodular subtype

9. No perineural involvement-(no neurological deficits grossly) -

Exclusion Criteria:

1. Location

2. Area M tumor size > or = to 10 mm

3. Area H tumor size > or = to 6 mm

4. Poorly defined borders

5. Recurrent BCC

6. Patient is immunosuppressed

7. There has been prior radiotherapy to the site -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson Univeristy	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

• Principal Investigator: Jason Lee, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT02579551
• Other Study ID Numbers: 11D.479; NCI-2015-01624
• First Posted: Oct 19, 2015
• Last Update Posted: Apr 25, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Basal Cell

Study Results

No Results Posted as of Apr 25, 2018