CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU
研究概览
简要总结
observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations.
详细描述
All patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy.
Patients will be evaluated with 12-lead ECG and blood sample for TnI and NT pro-BNP before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle.
All patients developing cardiovascular events will be submitted to blood sample for TnI, NT-proBNP, hsTnI and cardiac examination.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Age ≥ 18 years
- •Histologically confirmed adenocarcinoma of colon or rectum (any T, any N, any M) receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations
排除标准
- •Prior treatment with fluoropyrimidines
- •Prior or concurrent chest radiotherapy
- •Any prior or concurrent treatment with cardiotoxic drug
- •Any serious or uncontrolled cardiovascular disease (defined by the specialist during cardiac examination, see section 6.3.2 for details )
结局指标
主要结局
Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU
时间窗: 24 months
次要结局
未报告次要终点