Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 225
- 主要终点
- survival
研究概览
简要总结
RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer.
详细描述
OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery (VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients. III. Describe the complications associated with this procedure. IV. Describe the length of the operative procedure, duration of chest tube stay, and length of hospitalization in this patient population. V. Describe the survival and failure-free survival, over a 5-year period, in this patient population following this procedure.
OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.
PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
survival
时间窗: up to 5 years
failure-free survival
时间窗: up to 5 years
次要结局
未报告次要终点
