title: Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001).
abstract: This randomized, phase II, multicenter clinical trial was conducted to evaluate the feasibility of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection compared with open distal gastrectomy (ODG) for the treatment of advanced gastric cancer (AGC).
  
  
  
  D2 lymph node dissection has been accepted as standard treatment for AGC. Although LADG is widely performed in early gastric cancer (EGC), the feasibility of LADG in AGC has not been proven yet.
  
  
  
  Patients with cT2-T4a and cN0-2 (AJCC 7 staging system) distal gastric cancer were randomly but not blindingly assigned to LADG or ODG groups using fixed block sizes with a 1:1 allocation ratio. The primary endpoint was the noncompliance rate of the lymph node dissection, which was used to evaluate feasibility. Secondary endpoints included 3-year disease-free survival (DFS), 5-year overall survival, complications, and surgical stress response.
  
  
  
  Between June 2010 and October 2011, 204 patients enrolled and underwent either LADG (n = 105) or ODG (n = 99). Of these, 196 patients (100 in LADG and 96 in ODG) were included in the intention-to-treat analysis. There were no significant differences in the overall noncompliance rate of lymph node dissection between LADG and ODG groups (47.0% and 43.2%, respectively; P = 0.648). In the subgroup analysis, the noncompliance rate in the LADG group was significantly higher than the ODG group for clinical stage III disease (52.0% vs 25.0%, P = 0.043). No difference was found in the 3-year DFS rate between the groups (LADG, 80.1%; ODG, 81.9%; P = 0.448). Differences in postoperative complication rates and surgical stress response were found to be insignificant between the 2 arms.
  
  
  
  LADG was feasible for AGC treatment based on the noncompliance rate of D2 lymph node dissection. Subgroups analysis data suggest that further studies are needed for stage III gastric cancer.
authors.affiliation: Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun-gun, Republic of Korea.
authors.forename: Young Kyu
authors.initials: YK
authors.lastname: Park
authors.affiliation: Center for Gastric Cancer, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Hong Man
authors.initials: HM
authors.lastname: Yoon
authors.affiliation: Graduate School of Cancer Science and Policy, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Young-Woo
authors.initials: YW
authors.lastname: Kim
authors.affiliation: Center for Gastric Cancer, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Ji Yeon
authors.initials: JY
authors.lastname: Park
authors.affiliation: Center for Gastric Cancer, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Keun Won
authors.initials: KW
authors.lastname: Ryu
authors.affiliation: Department of Surgery, Gyeongsang National University Hospital, Jinju-si, Republic of Korea.
authors.forename: Young-Joon
authors.initials: YJ
authors.lastname: Lee
authors.affiliation: Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun-gun, Republic of Korea.
authors.forename: Oh
authors.initials: O
authors.lastname: Jeong
authors.affiliation: Department of Surgery, Kosin University Gospel Hospital, Busan, Republic of Korea.
authors.forename: Ki Young
authors.initials: KY
authors.lastname: Yoon
authors.affiliation: Center for Gastric Cancer, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Surgery, Konyang University Hospital, Daejeon, Republic of Korea.
authors.forename: Sang Eok
authors.initials: SE
authors.lastname: Lee
authors.affiliation: Department of Surgery, Kyungpook National University Hospital, Daegu, Republic of Korea.
authors.forename: Wansik
authors.initials: W
authors.lastname: Yu
authors.affiliation: Department of Surgery, Gyeongsang National University Hospital, Jinju-si, Republic of Korea.
authors.forename: Sang-Ho
authors.initials: SH
authors.lastname: Jeong
authors.affiliation: Department of Surgery, Dae Gu Veterans Hospital, Daegu, Republic of Korea.
authors.forename: Taebong
authors.initials: T
authors.lastname: Kim
authors.affiliation: Biometric Research Branch, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Sohee
authors.initials: S
authors.lastname: Kim
authors.affiliation: Biometric Research Branch, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Byoung-Ho
authors.initials: BH
authors.lastname: Nam
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005743:Gastrectomy / Q000009:adverse effects / Q000379:methods*; D019983:Guideline Adherence; D006801:Humans; D057194:Intention to Treat Analysis; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D008197:Lymph Node Excision; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D013312:Stress, Physiological