NCT01072838终止2 期
Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- SenoRx, Inc.
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
研究概览
简要总结
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Life expectancy > 10 years
- •Lumpectomy with clear margins (negative per NSABP criteria)
- •DCIS and/or invasive carcinoma
- •If invasive, nodes must be negative
- •T stage is Tis, T1 or T2<=3 cm max diameter
- •ER(+) or ER(-)/PR(+)
排除标准
- •Pregnant or breast feeding
- •Active collagen-vascular disease
- •Paget's disease of the breast
- •Prior history of breast cancer
- •Prior breast or thoracic radiotherapy
- •Multicentric carcinoma
- •Synchronous bilateral breast cancer
- •Surgical margins that cannot be assessed or that are positive
- •T Stage is T2>3 cm or greater
- •ER(-)/PR(-)
研究组 & 干预措施
Dose Escalation
Other
干预措施: APBI (Dose Escalation) (Radiation)
Dose Escalation
Other
干预措施: Contura MLB Breast Brachytherapy Catheter (Device)
结局指标
主要结局
Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (6)
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