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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05252065
• Other study ID #: GuizhouMuu
• Status: Not yet recruiting
• Start date: February 28, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Guizhou Medical University
• Contact: Yiying Zhu
• Phone: +8515989775891
• Email: 347454648[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guizhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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