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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The early intervention group | Experimental | The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include:
|
|
| The control group | No Intervention | This group will be under observation. When cardiovascular events (including ischemic cardiomyopathy, heart failure, arrhythmia requiring treatment, pericardial disease requiring treatment, valvular disease, etc.) happen, a cardiovascular specialist assessment and intervention will be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple cardiovascular drugs related to "Golden Triangle" | Drug | Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | It was calculated from the first day of treatment to the day of death. | 2-year |
| The incidence of grade 2+ cardiotoxicity events | Culmulative incidence of grade 2+ cardiotoxicity events | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From the first day of treatment to the day of progression or the day of death. | 2-year |
| The incidence of grade 2+ pulmonary toxicity | Culmulative incidence of grade 2+ pulmonary toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Qiu | Contact | +862087343031 | qiubo@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hui Liu, Professor | Sun yat-sen universtiy cancer center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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