Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer Treated With Conventional Radiotherapy

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Other: Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with NSCLC<br>all stage N2-3 non-small cell lung cancer patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy. | Other: Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging<br>* Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected for cardiac biomarkers;echocardiography and cardiac magnetic resonance imaging are used to measure the functions of heart and vessels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP | 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 | through study completion, an average of 1 year | 
| Global longitudinal strain value | 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 | through study completion, an average of 1 year | 
| The average flow velocity of the anterior descending coronary artery | obtained by phase contrast magnetic resonance arteriography of cardiac magnetic resonance imaging | through study completion, an average of 1 year |