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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Yiying Zhu; Phone Number: +8515989775891; Email: 347454648@qq.com
• Study Contact Backup: Name: Bing Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with stage N2-3 non-small cell lung cancerreceive intensity-modulated radiotherapy (IMRT) from Guizhou medical university affiliated cancer hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with NSCLC; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guizhou Medical University
• Investigators: Study Chair: Bing Lu, Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: GuizhouMuu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No