TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 706
- 试验地点
- 1
- 主要终点
- Number of participants with cardiovascular events in relation with the received heart radiation dose
研究概览
简要总结
Rationale:
The number of breast cancer (BC) patients at risk for long-term radiation-induced health problems is increasing, as their outcome is improving due to intensified treatment regimens, such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with the highest risk for radiation-induced health problems is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender.
- •Treated for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS).
- •Treated with curative breast-conserving surgery followed by radiotherapy of the breast, with or without irradiation of the regional lymph nodes.
- •Start of radiotherapy is between 01-01-2005 and 31-12-
- •Available planning CT scan and dose distribution data of original breast cancer irradiation.
排除标准
- •Any prior malignancy other than non-melanoma skin cancer or breast cancer.
- •Prior radiotherapy treatments in the thoracic region.
- •Treated with neoadjuvant chemotherapy.
结局指标
主要结局
Number of participants with cardiovascular events in relation with the received heart radiation dose
时间窗: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with hypothyroidism in relation with the received radiation dose
时间窗: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with radiation pneumonitis in relation with the received lung radiation dose
时间窗: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with secondary malignancies in relation with the received radiation dose
时间窗: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
次要结局
未报告次要终点