JCOG 1211：T1N0磨玻璃非小细胞肺癌肺段切除术的非随机验证性研究

JCOG1211
评价基于薄层CT的肺段切除术治疗T1N0期GGO为主型肺癌的安全性和有效性，肿瘤长径＞2cm，≤3cm，CTR≤0.5/肿瘤长径≤2cm，0.25＜CTR≤0.5/肿瘤长径≤2cm，CTR≤0.25，非周围型

Aokage K, Saji H, Suzuki K, Mizutani T, Katayama H, Shibata T, Watanabe S, Asamura H; Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group. A non-randomized confirmatory trial of segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-section computed tomography (JCOG1211). Gen Thorac Cardiovasc Surg. 2017 May;65(5):267-272. doi: 10.1007/s11748-016-0741-1. Epub 2017 Mar 2. PMID: 28255781.
Abstract

Introduction: Lobectomy has been the standard surgery for even stage I lung cancer since the validity of limited resection for stage I lung cancer was denied by the randomized study reported in 1995. The aim of this non-randomized confirmatory going on since September 2013 is to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-slice computed tomography.

Method: A total of 390 patients from 42 Japanese institutions are recruited within 4 years. The primary endpoint of this study is a 5-year relapse-free survival in all of the patients who undergo a segmentectomy for a lung nodule. The secondary endpoints are overall survival, annual relapse-free survival, disease-free survival, proportion of local relapse, postoperative pulmonary function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, adverse events, and serious adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000011819 ( http://www.umin.ac.jp/ctr/ ).

Results: Patient's accrual has been already finished in November, 2015 and the primary analysis will be performed in 2021.

Conclusion: This study is one of the pivotal trial of lung segmentectomy for early lung cancer. The result will provide a clear evidence for our daily clinics and will be possible contribution to preserving pulmonary function for lung cancer patients.

Aokage K, Saji H, Suzuki K, Mizutani T, Katayama H, Shibata T, et al. A non-randomized confirmatory trial of segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-section computed tomography (JCOG1211). Gen Thorac Cardiovasc Surg. 2017;65:267–72.