Phase II Study of LUNG Stereotactic Adaptive Ablative Radiotherapy for Central and Ultracentral Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Number of patients experiencing adverse events
研究概览
简要总结
The proposed study expands on the principles of SBRT (Stereotactic Body Radiation Therapy) and SABR (Stereotactic Ablative Radiotherapy) for centrally located NSCLC (Non-Small Cell Lung Cancer) to further optimize outcomes in this patient population with utilization of the adaptive workflow to maintain tumor control rates but decrease the incidence and grade of treatment-related toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years of age
- •Clinical diagnosis of NSCLC
- •Stage T1-2b (≤ 5 cm)
排除标准
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (i.e., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 1 year is permitted;
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Prior chemotherapy for the study cancer
- •Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression
- •Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression
结局指标
主要结局
Number of patients experiencing adverse events
时间窗: 12-month of treatment
No greater than 15 percent of patients experience a 12-month ≥ grade 3 toxicity and ≤1 grade 5 toxicity possibly, probably, or definitely related to treatment.
Treatment completion
时间窗: Plus or minus 5 days of treatment
Number of patients who completed treatment within +/- 5 days of intended treatment.
次要结局
- Functional Assessment of Cancer Therapy - Lung (FACT-L)(Baseline)
- Progression-free survival (PFS)(1 year of treatment)
- EQ-5D-5L(3 and 12-month follow-up)
- Late-Toxicity(1 year of treatment)
- Primary Tumor Control Rate(1 year of treatment)
- Overall survival (OS)(1 year of treatment)