Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

Non-small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980716
• Other study ID #: GASTO-1074
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: October 2022
• Source: Sun Yat-sen University
• Contact: Bo Qiu
• Phone: +862087343031
• Email: qiubo[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (no intervention time point for those who do not receive neoadjuvant therapy), before the first course of radiotherapy, 3-4 weeks after the first course of radiotherapy, 2 months after the second course of radiotherapy, 8 months after the second course of radiotherapy, 14 months after the second course of radiotherapy .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 524
• Est. completion date: July 1, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cardiovascular Complication
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Multiple 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.

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	It was calculated from the first day of treatment to the day of death.	2-year
Secondary	Cumulative incidence of cardiotoxicity events	Cumulative incidence of = Grade 3 cardiotoxicity events	2-year
Secondary	Progression-free survival	From the first day of treatment to the day of progression or the day of death.	2-year