Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.
Overview
- Phase
- Phase 3
- Intervention
- Multiple cardiovascular drugs related to "Golden Triangle"
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 524
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy.
Detailed Description
This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy. The participants were 1:1 randomized to the intervention group and the control group. The intervention group will receive cardiovascular evaluation and intervention at multiple timepoints throughout treatment and follow-up, while the control group will be under observation unless severe cardiovascular events happen. The evaluation and intervention timepoints include: Before neoadjuvant therapy, before radiotherapy, Mid-radiotherapy, 2 months after the completion of radiotherapy, every 6 months thereafter for up to 2 years post-radiotherapy.
Investigators
Hui Liu
Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;
- •Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
- •Male or female between 18 and 75 years old;
- •Life expectancy ≥ 12 weeks;
- •The World Health Organization (WHO) PS score is 0 or 1;
- •Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN;
- •A signed informed consent form is required before proceeding with any step in the research;
- •There is an abnormality in the initial cardiac output index.
Exclusion Criteria
- •PS score 2-4;
- •Organ function impairment: FEV1 \<1000ml; absolute neutrophil count \<1.5×10\^9/L; platelets \<100×10\^9/L; hemoglobin \<90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula \<50 mL/min; serum bilirubin\>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase\>2.5 times ULN;
- •Unstable angina or myocardial infarction occurred in the past month;
- •Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
- •Active endocarditis;
- •Symptomatic severe aortic stenosis;
- •Heart failure that has not been controlled;
- •Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
- •Suspected or confirmed aortic dissection;
- •Uncontrolled bronchial asthma;
Arms & Interventions
The early intervention group
The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include: 1. cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle" 1. ACEI, perindopril tert-butyrate 4mg qd 2. β receptor antagonist, metoprolol succinate 47.5mg qd 3. Spironolactone 20mg qd 4. Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid 5. Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc. 2. Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results.
Intervention: Multiple cardiovascular drugs related to "Golden Triangle"
Outcomes
Primary Outcomes
Overall survival
Time Frame: 2-year
It was calculated from the first day of treatment to the day of death.
The incidence of grade 2+ cardiotoxicity events
Time Frame: 2-year
Culmulative incidence of grade 2+ cardiotoxicity events
Secondary Outcomes
- Progression-free survival(2-year)
- The incidence of grade 2+ pulmonary toxicity(2-year)