Clinical trial NCT01903239: Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
Official title: Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Cell Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Advanced Aesthetics
First posted: 2013-07-19
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are evaluated.

Detailed description: Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.

Eligibility criteria: Inclusion Criteria:

* Patient has a BCC \<10mm on their cheeks, forehead, scalp \& neck or \<6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
* The BCC has well defined borders
* The BCC is primary
* The Patient is not immunosuppressed
* The BCC is not located at a site of prior radiation therapy
* The histologic subtype is nodular or superficial
* There is no perineural involvement

Exclusion Criteria:

* Patient has a BCC \>or=10mm on their cheeks, forehead, scalp \& neck or \>or=6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
* The BCC has poorly defined borders
* The BCC is recurrent
* The Patient is immunosuppressed
* The BCC is located at a site of prior radiation therapy
* The histologic subtype is aggressive
* There is perineural involvement

Primary outcomes:
measure: Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bensalem
country: United States
facility: Advanced Aesthetics
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Dermatology Associates
state: Pennsylvania
Study officials:
affiliation: Jefferson Dermatology Associates
name: Jason B Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: