Cardiovascular Complication, Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Cardiovascular Intervention, Impedance Cardiography, Cardiovascular Event
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.
Interventions
DRUGMultiple cardiovascular drugs related to Golden Triangle
Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Plan to receive radical radiotherapy and chemotherapy ± immunotherapy; 3. Male or female between 18 and 75 years old; 4. Life expectancy ≥ 12 weeks; 5. The World Health Organization (WHO) PS score is 0 or 1; 6. 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; 7. A signed informed consent form is required before proceeding with any step in the research; 8. There is an abnormality in the initial cardiac output index.
Exclusion criteria
1. PS score 2-4; 2. 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; 3. Unstable angina or myocardial infarction occurred in the past month; 4. Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics; 5. Active endocarditis; 6. Symptomatic severe aortic stenosis; 7. Heart failure that has not been controlled; 8. Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation; 9. Suspected or confirmed aortic dissection; 10. Uncontrolled bronchial asthma; 11. Pulmonary edema; 12. Fingertip blood oxygen saturation at rest ≤85%; 13. Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise; 14. Mental disorders make it impossible to cooperate. 15. Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2-year | It was calculated from the first day of treatment to the day of death. |
| The incidence of grade 2+ cardiotoxicity events | 2-year | Culmulative incidence of grade 2+ cardiotoxicity events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2-year | From the first day of treatment to the day of progression or the day of death. |
| The incidence of grade 2+ pulmonary toxicity | 2-year | Culmulative incidence of grade 2+ pulmonary toxicity |
Countries
China
Contacts
Primary ContactBo Qiu
Outcome results
None listed