A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer in Chinese Population
The prospective randomized LCSG trial of lobectomy versus limited resection for stage IA
non-small cell lung cancer (NSCLC) disproved sublobar resection as a comparable surgical
treatment to lobectomy. However, the role of sublobar resection is still in dispute
considering the dramatic improvement in radiographic technology, minimal invasive surgical
technique and significant advances in our understanding of the biology of NSCLC in the
subsequent 20 years. And Recent meta-analysis revealed survival after limited resection for
stage I lung cancer was comparable to that after lobectomy. This is a nationwide,
multicenter, prospective, randomized open phase III study, aimed To evaluate the 5 year
overall survival (OS) rate of two types of surgery. Patients are stratified according to
tumor size, histology, smoking status and institutions. Patients are randomized to 1 of 2
- Arm I: Patients undergo lobectomy by thoracotomy or thoracoscopy/VATS.
- Arm II: Patients undergo sublobar resection(wedge resection or anatomical
segmentectomy) by thoracotomy or thoracoscopy/VATS.
patients will be followed up every 6 months for 2 years and annually for 5 years
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the 5 year overall survival (OS) rate of two groups.
Jun Wang, MD
Peking University People's Hospital
China: Food and Drug Administration