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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
610
segmentectomy in Arm I and lobectomy in Arm II
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Relapse-free survival
To evaluate the 5 year relapse-free survival (RFS) rate of two groups.
Time frame: 5 years
overall survival
To evaluate the 5 year overall survival (OS) rate of two groups.
Time frame: 5 years
Pulmonary function
to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months and 12 months postoperatively.
Time frame: 6 months and 12 months
the duration of postoperative hospital stay
to evaluate the postoperative inpatient days of the two groups.
Time frame: an expected average of 5 days
performance status
to evaluate the postoperative performance status of the two groups by ECOG score standard.
Time frame: 12 months
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