Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer in Reducing Early Cardiac Injury: a Phase II Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Incidence of clinical or subclinical cardiac injury
研究概览
简要总结
Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.
详细描述
Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary left-sided breast cancer post surgery
- •Planning for adjuvant breast/chest wall +-RNI
排除标准
- •History of cardiovascular disease
- •Previous chest radiation
- •Bilateral breast cancers
结局指标
主要结局
Incidence of clinical or subclinical cardiac injury
时间窗: two years
predefined cardiac events
次要结局
未报告次要终点
研究者
Shu lian Wang
Professor
Chinese Academy of Medical Sciences