Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 7
- 主要终点
- Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
研究概览
简要总结
A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors.
While recent research has identified SABR as a promising method to increase local control (LC) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. This study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, > 10 cc).
This is a study of the procedure stereotactic ablative radiotherapy (SABR). It is not a study of a specific drug or device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
时间窗: 1 year
Local tumor control was assessed by CT, PET-CT, and, if appropriate, biopsy. The outcome was reported as the number of lesions that maintained tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment.
次要结局
- Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors(1 year)
- Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors(up to 2 years)
- Number of Participants With a Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR)(up to 2 years)
- Number of Participants With Progression-free Survival (PFS)(up to 2 years)
- Number of Participants With Metastasis-free Survival (MFS)(2 years)
- Number of Participants With Overall Survival (OS)(2 years)
研究者
Maximilian Diehn
Professor of Radiation Oncology (Radiation Therapy)
Stanford University