Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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