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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Skin Basal Cell Carcinoma

Treatments: Procedure: Therapeutic Conventional Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02579551

JT 2143 (Other Identifier)

NCI-2015-01624 (Registry Identifier)

11D.479

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 patients

Sex: All

Volunteers: No 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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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179 participants in 1 patient group

Treatment (surgical excision)

Experimental group

Description:

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

Treatment:

Procedure: Therapeutic Conventional Surgery