Keiju Aokage1, Hisashi Saji2, Kenji Suzuki3, Tomonori Mizutani4, Hiroshi Katayama4, Taro Shibata4, Syunichi Watanabe5, Hisao Asamura6. 1. Division of Thoracic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. kaokage@east.ncc.go.jp. 2. Department of Chest Surgery, St. Marianna University School of Medicine, Kanagawa, Japan. 3. Division of General Thoracic Surgery, Juntendo University Hospital, Tokyo, Japan. 4. JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan. 5. Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan. 6. Division of Thoracic Surgery, Keio University School of Medicine, Tokyo, Japan.
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.
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 cancerpatients.
Authors: T Aoki; Y Tomoda; H Watanabe; H Nakata; T Kasai; H Hashimoto; M Kodate; T Osaki; K Yasumoto Journal: Radiology Date: 2001-09 Impact factor: 11.105
Authors: M Noguchi; A Morikawa; M Kawasaki; Y Matsuno; T Yamada; S Hirohashi; H Kondo; Y Shimosato Journal: Cancer Date: 1995-06-15 Impact factor: 6.860
Authors: Marcello Migliore; Mariaconcetta Fornito; Manuela Palazzolo; Alessandra Criscione; Mariapia Gangemi; Francesco Borrata; Paolo Vigneri; Marco Nardini; Joel Dunning Journal: Ann Transl Med Date: 2018-03