TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,133
- 试验地点
- 1
- 主要终点
- Number of Patients With Local Recurrence
研究概览
简要总结
Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT
详细描述
Quality Control Registry of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 Gy at the applicator surface as an advanced boost followed by a shortened external beam radiotherapy. This is a prospective phase IV study to evaluate real life data of IORT Boost. Study runs in Germany with 13 active centers recruiting. Due to the nature of the study (registry) there is no need for randomization. Inclusion of n = >1000 patients is planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tumor diameter < 3,5 cm
- •Informed consent
排除标准
- •No informed consent
- •Tumor size > 3,5 cm
- •No indication for a boost
结局指标
主要结局
Number of Patients With Local Recurrence
时间窗: 5 years
The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate
次要结局
- Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost(84 months)
研究者
Elena Sperk, MD
Senior Consultant, Managing Director Clinical Trials Unit Mannheim Cancer Center
Universitätsmedizin Mannheim