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临床试验/NCT00003692
NCT00003692已完成2 期

Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study

Alliance for Clinical Trials in Oncology225 个研究点 分布在 1 个国家目标入组 128 人开始时间: 1998年12月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (225)

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