NCT00144898已完成3 期
A Randomized, Phase III Clinical Trial GF-GS 01 to Compare Conventional Axillary Dissection Versus Sentinel Node Resection (GS) in Clinically Node-negative Operable Breast Cancer Unifocal N0 Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,627
- 试验地点
- 2
- 主要终点
- Survival without recurrence
研究概览
简要总结
Sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer.
The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new surgical method with a classical method in patients having a negative sentinel node.
The duration of the follow-up is 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years with clinically node-negative operable unifocal N0 breast cancer (clinical tumour size < 30 mm).
- •Written consent is obtained from all patients before randomization.
排除标准
- 未提供
研究组 & 干预措施
Sentinel Node Resection
Experimental
Sentinel Node Resection
干预措施: Sentinel Node Resection (Procedure)
Conventional Axillary Dissection
Other
Conventional Axillary Dissection
干预措施: Conventional Axillary Dissection (Procedure)
结局指标
主要结局
Survival without recurrence
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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