NCT03211442已完成不适用
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Number of patients with an Acute Coronary Event after completion of RT treatment
研究概览
简要总结
MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer patients;
- •Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS);
- •Age between 40-75 years at time of start RT;
- •WHO performance status 0-1;
- •Planned for RT alone to the breast, the chest wall and/or the lymph node areas;
- •Start of RT is between 01-01-2015 and 31-12-2013;
- •Available planning CT scan and dose distribution;
- •Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed;
- •Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion;
- •Written informed consent.
排除标准
- •Male breast cancer patients;
- •Women with metastatic breast cancer (M1 disease);
- •Any prior malignancy other than non-melanoma skin cancer;
- •Previous thoracic or mediastinal radiation;
- •Women treated with neoadjuvant chemotherapy.
结局指标
主要结局
Number of patients with an Acute Coronary Event after completion of RT treatment
时间窗: First 10 years after RT treatment
次要结局
- Number of patients with other cardiac complications after completion of RT treatment(First 10 years after RT treatment)
- Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)(First 10 years after RT treatment)
研究者
研究点 (1)
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