A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)
试验速览
- 阶段
- 3 期
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- Relapse-free survival
研究概览
简要总结
Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).
详细描述
Objective
To compare the outcomes(including 5 year relapse free survival rate, 5 year overall survival rate, retaining pulmonary function and the rates of loco-regional and systemic recurrence ) of patients with peripheral stage IA (≤ 2 cm) non-small cell lung cancer undergoing anatomic segmentectomy vs lobectomy. And to evaluate whether the anatomic segmentectomy is an optimal type of surgery for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC).
Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
- Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative criteria:
- •ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.
- •ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.
- •Intraoperative criteria:
- •ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.
- •ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible.
- •ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.
- •ECOG performance status 0-
- •No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix).
- •No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
- •No prior chemotherapy or radiation therapy.
- •Lobectomy is tolerated.
- •Sufficient organ functions.
- •Written informed consent.
排除标准
- •Active bacterial or fungous infection.
- •Simultaneous or metachronous (within the past 5 years) multiple cancers.
- •Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
- •Uncontrollable diabetes mellitus.
- •History of severe heart disease.
- •The maximal diameter of GGO≤5mm.
- •N1, N2, or M1a is confirmed postoperatively.
- •Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).
- •Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.
- •Confirmation of benign disease by postoperative pathologic examination.
- •Lesion located in the middle lobe.
结局指标
主要结局
Relapse-free survival
时间窗: 5 years
To evaluate the 5 year relapse-free survival (RFS) rate of two groups.
次要结局
- performance status(12 months)
- Pulmonary function(6 months and 12 months)
- overall survival(5 years)
- the duration of postoperative hospital stay(an expected average of 5 days)