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

NCT ID: NCT05252065

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-12-30

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guizhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bing Lu

Role: STUDY_CHAIR

Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University

Central Contacts

Yiying Zhu

Role: CONTACT

347454648@qq.com

+8515989775891

Bing Lu

Role: CONTACT

Other Identifiers

GuizhouMuu

Identifier Type: -

Identifier Source: org_study_id