RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
研究概览
简要总结
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
详细描述
To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer).
- To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
- To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathologically confirmed small cell lung cancer, limited or extensive stage.
- •Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering 30-66 Gy in 15-33 fractions at 2 Gy per fraction, at the recommendation of the treating radiation oncologist.
- •Age 18 or greater
排除标准
- •Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
- •Pregnancy
结局指标
主要结局
Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
时间窗: Up to 1,2, and 5 years
The optimal frequency of conebeam CT during treatment will be determined by a mixed model: * The local control, distant metastases, patterns of failure will be summarized as frequency and percentage. * Chi-square test will be used to test their relationships with other categorical variables. * General linear model will be used to measure their association with continuous covariates with and without adjusting for other factors
Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).
时间窗: Up to 1 year from study start
Patients enrolled will experience \<35% incidence of cardiac events at 1-year. Cardiac events included are acute heart disease, acute myocardial infarction, cardiomyopathy, dysrhythmia, heart failure, pericarditis, and pericardial effusion.
次要结局
未报告次要终点
研究者
Sibo Tian
Principal Investigator, Associate Professor, Department of Radiation Oncology
Emory University