Anatomical segmentectomy versus wedge resection for small (≤2 cm) peripheral non-small cell lung cancer in 80 or more aged elderly patients: a randomized phase III study (JCOG2109, AWESOME).

The standard treatment for small-sized and peripherally located early-stage non-small cell lung cancer is segmentectomy with secured margins. However, in 80 or more aged elderly patients, whether wedge resection will provide a better prognosis than segmentectomy is controversial. The aim of this trial is to confirm the non-inferiority of wedge resection to anatomical segmentectomy in terms of overall survival in these patients, who can tolerate lobectomy, with small-sized (≤2 cm), radiological solid dominant (consolidation-to-tumour ratio >0.5) and peripherally located early-stage non-small cell lung cancer in a randomized phase III trial. The primary endpoint is overall survival. If the non-inferiority of overall survival and the minimal invasiveness of wedge resection are proven, it can be a new standard treatment for such patients. A planned total of 400 patients will be enrolled from 53 institutions in 5 years. This trial has been registered in the Japan Registry of Clinical Trials with code jRCT1030220482 (https://jrct.niph.go.jp/latest-detail/jRCT1030220482).