Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer Treated With Conventional Radiotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Global longitudinal strain value
研究概览
简要总结
Calculating which cardiac substructure accepting with the highest radiation dose by conventional radiotherapy, then to investigate the relationship between the changes of global longitudinal strain or cardiac magnetic resonance imaging and cardiac biomarkers and the certain cardiac substructure for stage N2-3 non-small cell lung cancer
详细描述
All patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy，Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected before radiotherapy, at the end of radiotherapy (day 15), at the end of radiotherapy and at 1 month after radiotherapy. Echocardiography was performed before radiotherapy, in the middle of radiotherapy (day 15) and at the end of radiotherapy to obtain global longitudinal strain value. Cardiac magnetic resonance imaging is used to measure the blood flow of the anterior descending coronary artery before and at the end of radiotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at TNM stage N2-N3 NSCLC confirmed by histopathology or cytology using IASLC International TNM staging standard (8th edition)
- •KPS score >80; Aged 18 to 75 year-old
- •No contraindications to radiotherapy
- •No history of heart disease before treatment
- •Patients receiving intensity modulated radiation therapy (IMRT)
- •Patients receiving PTV at a prescription dose of 60-70Gy by IMRT
- •Patients receiving radiotherapy alone and concurrent chemoradiotherapy
排除标准
- •Patients with pleural effusion
- •Patients with serious medical illness or infection
- •Patients with acute myocardial infarction within 6 months
- •In patients with NYHA grade 3-4, baseline LVEF before radiotherapy is below 59%
- •Patients with congenital heart diseases, valvular diseases and arrhythmia
- •Patients with pericardial effusion
- •Patients receiving immunotherapy and drug targeted therapy
- •Patients with a history of anthracycline use
结局指标
主要结局
Global longitudinal strain value
时间窗: through study completion, an average of 1 year
global longitudinal strain value is obtained by offline analysis of 2-dimensional Echocardiography, reduction of more than 15% in left ventricular systole suggests some degree of cardiotoxicity by European Society of Cardiology 2016
Concentration of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP
时间窗: through study completion, an average of 1 year
These levels are measured with the Siemens ADVIA Centaur XP Immunoassay System, normal ranges of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are 0-0.03 ng/mL, 0-0.01 ng/mL, 0-0.04 ng/mL, 0-100 pg/mL, and 0-125pg/mL respectively
The average flow velocity of the anterior descending coronary artery
时间窗: through study completion, an average of 1 year
obtained by phase contrast magnetic resonance arteriography of cardiac magnetic resonance imaging
次要结局
未报告次要终点