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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
524
Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGOverall survival
It was calculated from the first day of treatment to the day of death.
Time frame: 2-year
The incidence of grade 2+ cardiotoxicity events
Culmulative incidence of grade 2+ cardiotoxicity events
Time frame: 2-year
Progression-free survival
From the first day of treatment to the day of progression or the day of death.
Time frame: 2-year
The incidence of grade 2+ pulmonary toxicity
Culmulative incidence of grade 2+ pulmonary toxicity
Time frame: 2-year
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