title: A randomized controlled trial comparing laparoscopic surgery with open surgery in palliative resection of primary tumor in incurable Stage IV colorectal cancer: Japan Clinical Oncology Group Study JCOG 1107 (ENCORE trial).
abstract: A randomized controlled trial was started in Japan to evaluate the non-inferiority of overall survival of laparoscopic surgery to open surgery for palliative resection of primary tumor in incurable Stage IV colorectal cancer. Symptomatic, Stage IV colorectal cancer patients with non-curable metastasis are pre-operatively randomized to either open or laparoscopic colorectal resection. Surgeons in 56 specialized institutions will recruit 450 patients. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, the proportion of conversion from laparoscopic surgery to open surgery, the proportion of patients who fulfill the criteria of starting chemotherapy by 6 weeks after operation, intraoperative and post-operative complications, adverse events during chemotherapy and serious adverse events.
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita inomata@oita-u.ac.jp.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Inomata
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Akagi
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Katayama
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Aya
authors.initials: A
authors.lastname: Kimura
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: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Etoh
authors.affiliation: Department of Gastroenterological Surgery, Comprehensive Cancer Center, Saitama International Medical Center, Saitama Medical University, Saitama.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Yamaguchi
authors.affiliation: National Cancer Center Hospital East, Chiba.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Ito
authors.affiliation: Shizuoka Cancer Center, Shizuoka.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Kinugasa
authors.affiliation: Toho University School of Medicine Ohashi Hospital, Tokyo.
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Saida
authors.affiliation: Keio University Hospital, Tokyo.
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Hasegawa
authors.affiliation: Department of Surgery, Gastroenterological Center, Yokohama City University, Kanagawa.
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Ota
authors.affiliation: Department of Colorectal Surgery Division, National Cancer Center Hospital, Tokyo.
authors.forename: Yukihide
authors.initials: Y
authors.lastname: Kanemitsu
authors.affiliation: Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita.
authors.forename: Seigo
authors.initials: S
authors.lastname: Kitano
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery; D061887:Conversion to Open Surgery / Q000706:statistics & numerical data; D018572:Disease-Free Survival; D007564:Japan; D010535:Laparoscopy; D009367:Neoplasm Staging; D010166:Palliative Care / Q000379:methods; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
keywords: colorectal cancer; laparoscopic surgery; palliative resection; randomized controlled trial