Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Success rate for 1 mm margins
研究概览
简要总结
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.
详细描述
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.
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
- •Area M (cheeks, forehead, scalp & neck) tumor size < 10 mm
- •Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear) tumor size < 6 mm
- •Well-defined borders
- •Primary BCC
- •Patient is not immunosuppressed
- •There has not been prior radiotherapy to the site
- •Nodular subtype
- •No perineural involvement-(no neurological deficits grossly) -
排除标准
- •Area M tumor size > or = to 10 mm
- •Area H tumor size > or = to 6 mm
- •Poorly defined borders
- •Recurrent BCC
- •Patient is immunosuppressed
- •There has been prior radiotherapy to the site -
研究组 & 干预措施
Treatment (surgical excision)
Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Success rate for 1 mm margins
时间窗: 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
时间窗: 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.
次要结局
- Recurrence rate after 3 years(Up to 3 years)