A Phase II Clinical Trial of Image Guided Stereotactic Ablative Radiotherapy (SABR) for T2 and Microscopic T3 (PL3), N0,M0 Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
研究概览
简要总结
This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.
详细描述
Treatment Plan:
7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT).
- Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred.
- All doses are prescribed to the tumor periphery.
For this protocol, patients will be followed only up to 2 years post radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Non-Small Cell Lung Cancer
- •T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm
- •Surgically inoperable
- •ECOG Performance 0-2
排除标准
- •Pacemaker on the same side of the tumor
- •Infection that requires IV antibiotics
- •Concomitant or adjuvant anti-neoplastic chemotherapy
结局指标
主要结局
Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
时间窗: 2 years
次要结局
- Best Response(2 years)