Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer Treated With Breast Conserving Surgery Followed by Radiotherapy With Free-breathing or Deep Inspiration Breath-hold (DIBH) Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.
详细描述
Patients with left-sided breast cancer treated with breast conserving surgery are prospectively enrolled. Two types of radiation treatment are delivered based on attending physician's preferences: radiation to whole breast +- regional nodal areas with free-breathing technique, or with deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters including heart dose and the dose to left anterior coronary artery are assessed, and the cardiac toxicities regularly assessed with cardiac enzymes,electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging before, during and after radiation.The dose-effect relationship of heart injuries is analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Left-sided breast cancer
- •Underwent breast conserving surgery
- •Planned for postoperative whole breast +- regional nodal radiotherapy
- •No basic heart disease
排除标准
- •Abnormal cardiac baseline examination
- •History of chest radiation
- •Can not tolerate deep inspiratory breath-holding
结局指标
主要结局
Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0
时间窗: up to 2 years
The cardiac adverse events are regularly assessed with cardiac symptoms,cardiac enzymes(TnT，BNP),electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging.
次要结局
未报告次要终点
研究者
Shu lian Wang
professor of medicine
Chinese Academy of Medical Sciences