Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
试验速览
- 阶段
- 不适用
- 入组人数
- 179
- 试验地点
- 4
- 主要终点
- Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC
时间窗: 3 years
次要结局
未报告次要终点