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

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging

• Registration Number: NCT05252065
• Lead Sponsor: Guizhou Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-24
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-19
• Last Update Submitted: 2022-02-19
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23
• Study Start: 2022-02-28
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients at TNM stage N2-N3 NSCLC confirmed by histopathology or cytology using IASLC International TNM staging standard (8th edition)
2. KPS score >80; Aged 18 to 75 year-old
3. No contraindications to radiotherapy
4. No history of heart disease before treatment
5. Patients receiving intensity modulated radiation therapy (IMRT)
6. Patients receiving PTV at a prescription dose of 60-70Gy by IMRT
7. Patients receiving radiotherapy alone and concurrent chemoradiotherapy

Exclusion Criteria

1. Patients with pleural effusion
2. Patients with serious medical illness or infection
3. Patients with acute myocardial infarction within 6 months
4. In patients with NYHA grade 3-4, baseline LVEF before radiotherapy is below 59%
5. Patients with congenital heart diseases, valvular diseases and arrhythmia
6. Patients with pericardial effusion
7. Patients receiving immunotherapy and drug targeted therapy
8. Patients with a history of anthracycline use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with NSCLC	Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging	all stage N2-3 non-small cell lung cancer patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy.

Primary Outcome Measures

Name	Time	Method
Global longitudinal strain value	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	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	through study completion, an average of 1 year	obtained by phase contrast magnetic resonance arteriography of cardiac magnetic resonance imaging