title: A randomized Phase III trial of thoracoscopic versus open esophagectomy for thoracic esophageal cancer: Japan Clinical Oncology Group Study JCOG1409.
abstract: A randomized Phase III study was commenced in May 2015 to confirm the non-inferiority of thoracoscopic esophagectomy to open esophagectomy in terms of overall survival for clinical Stage I-III esophageal cancer. A total of 300 patients will be accrued from Japanese institutions over 6 years. The primary endpoint is overall survival. The secondary endpoints are relapse-free survival, proportion of patients with R0 resection, proportion of patients who underwent re-operation, adverse events, postoperative respiratory function change, postoperative quality-of-life score (EORTC QLQ-C30), and proportion of patients who need conversion from thoracoscopic surgery to open surgery. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017628.
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Kozo
authors.initials: K
authors.lastname: Kataoka
authors.affiliation: Department of Surgery, Keio University School of Medicine, Tokyo htakeuchi@a6.keio.jp.
authors.forename: Hiroya
authors.initials: H
authors.lastname: Takeuchi
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.affiliation: Division of Esophageal Surgery, Shizuoka Cancer Center, Shizuoka.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Tsubosa
authors.affiliation: Division of Esophageal Surgery, National Cancer Center Hospital, Tokyo.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Koyanagi
authors.affiliation: Division of Esophageal Surgery, National Cancer Center Hospital East, Chiba.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Daiko
authors.affiliation: Department of Surgery, Keio University School of Medicine, Tokyo.
authors.forename: Satoru
authors.initials: S
authors.lastname: Matsuda
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.affiliation: Department of Surgery, Keio University School of Medicine, Tokyo.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
mesh_terms: D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000601:surgery*; D009367:Neoplasm Staging; D018579:Patient Selection; D011184:Postoperative Period; D011788:Quality of Life; D012119:Respiration; D013906:Thoracoscopy; D016896:Treatment Outcome
keywords: Phase III; open esophagectomy; thoracoscopic esophagectomy