title: Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for operable gastric cancer, a randomized Phase II trial (LANDSCOPE trial).
abstract: This randomized Phase II trial will compare the efficacy and safety of laparoscopy-assisted D2 distal gastrectomy and open distal D2 gastrectomy after neoadjuvant chemotherapy for patients with macroscopically resectable serosa-positive gastric cancer. When R0/R1 surgery is achieved, patients receive S-1 chemotherapy for 1-year post-operatively. The primary endpoint is the 3-year disease-free survival. The sample size to test the hypothesis of the non-inferiority of laparoscopy-assisted D2 distal gastrectomy to open distal D2 gastrectomy is 80. This trial will be able to appraise the use of the laparoscopic approach as a curative D2 distal gastrectomy after neoadjuvant chemotherapy for gastric cancer.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815, Japan. yoshikawat@kcch.jp
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Tetsu
authors.initials: T
authors.lastname: Fukunaga
authors.forename: Masataka
authors.initials: M
authors.lastname: Taguri
authors.forename: Chikara
authors.initials: C
authors.lastname: Kunisaki
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sakuramoto
authors.forename: Seiji
authors.initials: S
authors.lastname: Ito
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D053208:Kaplan-Meier Estimate; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D018579:Patient Selection; D012107:Research Design; D012704:Serous Membrane / Q000473:pathology; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery*