A multi-institutional randomized phase III trial of lobectomy versus segmentectomy for radiologically solid-predominant non-small cell lung cancer with a ground-glass opacity and tumor diameter > 2 cm and ≤ 3 cm: JCOG2217 (STRONG)

Lobectomy has been the standard surgical procedure for clinical stage IA non-small cell lung cancer (NSCLC) since the results of a randomized trial in 1995. However, recent phase III trials have demonstrated the efficacy of segmentectomy for small NSCLC. Segmentectomy has become one of the standard treatments for peripheral lung cancers with a tumor diameter of ≤2 cm and further expansion of the indication for segmentectomy is considered. We planned this trial to confirm the non-inferiority of segmentectomy to lobectomy in terms of overall survival in patients with solid-predominant NSCLC with ground-glass opacity and > 2 cm and ≤ 3 cm in tumor diameter. Pure-solid tumors will be excluded because of their highly malignant characteristics. The primary endpoint is overall survival. A total of 515 patients from 53 institutions will be enrolled over 5 years. The trial has been registered in the Japan Registry of Clinical Trials (study number: jRCTs1030240027).