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

• Sponsor: Guizhou Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05252065
• Collaborator: (none)
• Enrollment: 40
• Anticipated Duration (Months): 10

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer Treated With Conventional Radiotherapy
• Anticipated Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Guizhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guizhou Medical University
• ClinicalTrials.gov Identifier: NCT05252065
• Other Study ID Numbers: GuizhouMuu
• First Posted: Feb 23, 2022
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Feb 23, 2022