NCT01717261已完成1 期
Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acute toxicity
研究概览
简要总结
The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.
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
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 60 years or older.
- •Invasive ductal carcinoma.
- •Unifocal disease.
- •Tumors less than 2cm.
- •No clinical evidence of nodal disease.
- •Estrogen receptor status (ER) positive.
- •Her2 negative.
排除标准
- •Age less than 60 years.
- •BRCA 1 and/or BRCA 2 mutation.
- •Tumour histology limited to lobular carcinoma only.
- •Neoadjuvant hormonal manipulation or chemotherapy.
- •More than one primary tumour in different quadrants of the same breast.
- •Inability to view tumor on imaging.
结局指标
主要结局
Acute toxicity
时间窗: 6 months
Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
次要结局
- Chronic toxicity(2 years)
- Cosmetic outcome(5 years)
研究者
Michael Yassa
Radiation Oncologist
Maisonneuve-Rosemont Hospital
研究点 (2)
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