Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | January 2017 |
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.
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.
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.
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.
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
We found this trial at
2
sites
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