Clinical trial NCT05252065: Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer
Official title: Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer Treated With Conventional Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Guizhou Medical University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Concentration of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP
timeFrame: through study completion, an average of 1 year
measure: Global longitudinal strain value
timeFrame: through study completion, an average of 1 year
measure: The average flow velocity of the anterior descending coronary artery
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University
name: Bing Lu
role: STUDY_CHAIR
References: