A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Clinical cardiopulmonary toxicities
研究概览
简要总结
The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.
详细描述
This aims to collect observational data that describe clinical (primary endpoint) and subclinical (secondary endpoint) cardiopulmonary toxicities from combined thoracic radiotherapy and immunotherapy up to 25 months after thoracic radiotherapy and 12 months after consolidation immunotherapy among patients with locally advanced lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years age
- •Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curative radiotherapy (45Gy and above) and planned consolidation immunotherapy.
- •Patients who are not receiving concurrent chemotherapy and radiotherapy are eligible.
- •Patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study.
- •ECOG performance status of 0-2
- •Life expectancy of 6 months or longer
- •Patient able to provide a written informed consent prior to study entry
排除标准
- •Prior thoracic radiotherapy to chest.
- •Patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy.
- •Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
结局指标
主要结局
Clinical cardiopulmonary toxicities
时间窗: 25 months
To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0
次要结局
- subclinical/asymptomatic cardiopulmonary events(25 months)
研究者
Bo Lu
Chair & Professor, Department of Radiation Oncology
University of Missouri-Columbia