title: A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric Cancer (JCOG0912).
abstract: A Phase III study was started in Japan to evaluate the non-inferiority of overall survival of laparoscopy-assisted distal gastrectomy with open distal gastrectomy in patients with clinical IA (T1N0) or IB [T1N1 or T2(MP)N0] gastric cancer. This study followed the previous Phase II study to confirm the safety of laparoscopy-assisted distal gastrectomy (JCOG0703) and began in March 2010. A total of 920 patients will be accrued from 33 institutions within 5 years. The primary endpoint is overall survival. The secondary endpoints are relapse-free survival, proportion of laparoscopy-assisted distal gastrectomy completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, postoperative quality of life. Only a credentialed surgeon can be responsible for both open distal gastrectomy and laparoscopy-assisted distal gastrectomy.
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Katai
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.forename: Masanori
authors.initials: M
authors.lastname: Terashima
authors.forename: Seiji
authors.initials: S
authors.lastname: Ito
authors.forename: Masakazu
authors.initials: M
authors.lastname: Takagi
authors.forename: Akinori
authors.initials: A
authors.lastname: Takagane
authors.forename: Motoki
authors.initials: M
authors.lastname: Ninomiya
authors.forename: Norimasa
authors.initials: N
authors.lastname: Fukushima
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery*; D002985:Clinical Protocols; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D010535:Laparoscopy; D008197:Lymph Node Excision; D008297:Male; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis