title: A non-randomized confirmatory trial of segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-section computed tomography (JCOG1211).
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Thoracic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. kaokage@east.ncc.go.jp.
authors.forename: Keiju
authors.initials: K
authors.lastname: Aokage
authors.affiliation: Department of Chest Surgery, St. Marianna University School of Medicine, Kanagawa, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Saji
authors.affiliation: Division of General Thoracic Surgery, Juntendo University Hospital, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Suzuki
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Mizutani
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Katayama
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Syunichi
authors.initials: S
authors.lastname: Watanabe
authors.affiliation: Division of Thoracic Surgery, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Asamura
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000601:surgery*; D000077192:Adenocarcinoma of Lung; D000328:Adult; D000368:Aged; D001706:Biopsy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008168:Lung / Q000000981:diagnostic imaging* / Q000601:surgery; D008175:Lung Neoplasms / Q000175:diagnosis / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods*; D011013:Pneumonectomy / Q000379:methods*; D014057:Tomography, X-Ray Computed / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Adenocarcinoma; Ground glass opacity; Lung cancer; Segmentectomy; Thin-slice computed tomography