Skin Basal Cell Carcinoma
Conditions
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.
Interventions
PROCEDURETherapeutic Conventional Surgery
Undergo surgical excision
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame |
|---|---|
| Recurrence rate after 3 years | Up to 3 years |
Countries
United States
Outcome results
None listed