NCT02114086进行中（未招募）不适用
Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- number of Participants with local recurrence histologically proven
研究概览
简要总结
In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with histologically proven unifocal ductal-invasive or other histology of breast-cancer, size of tumor < or = 3.5 cm
- •written informed consent
- •ability to cooperate
- •full legal capability
排除标准
- •missing written informed consent
- •lack of compliance
结局指标
主要结局
number of Participants with local recurrence histologically proven
时间窗: up to 10 years
Recurrence of breast cancer proven by histology
次要结局
- Quality of life(up to 10 years)
- Cosmesis(up to 10 years)
- Overall survival(up to 10 years)
- observation of acute and late effects of Radiotherapy(up to 10 years)
研究者
研究点 (1)
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