REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
研究概览
简要总结
The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.
详细描述
REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.
In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains,
- •Age between 40 and 70 years
- •Adjuvant Radiotherapy is helical tomotherapy performed at Institut Claudius Regaud(Toulouse, France)
排除标准
- •Indication of adjuvant chemotherapy
- •Clinically or radiologically detectable metastasis
- •Personal history of coronary artery or myocardial disease
- •Personal history of breast cancer or other cancer requiring radiotherapy to the chest
- •Contraindications to injection of iodinated contrast ( for CT ) : pregnancy , renal failure, allergy.
- •Pregnancy, lactation
- •Before radiotherapy, LVEF <50%
- •Before radiotherapy, longitudinal strain > - 16 %
- •Before radiotherapy,longitudinal strain rate <1% / s
- •Before radiotherapy, segmental wall motion abnormality
- •Coronary CT before radiotherapy showing that a therapeutic treatment is required
结局指标
主要结局
Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
时间窗: within the first 2 years after tomotherapy
The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam"2D strain" between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy .
次要结局
- Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")(within the first 6 months after tomotherapy)
- Number of participants with modified measures of circulating biomarkers(within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy))
研究者
Sophie JACOB
PhD
Institut de Radioprotection et de Surete Nucleaire