Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for operable gastric cancer, a randomized Phase II trial (LANDSCOPE trial)

Jpn J Clin Oncol. 2012 Jul;42(7):654-7. doi: 10.1093/jjco/hys057. Epub 2012 Apr 29.

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.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemotherapy, Adjuvant
  • Disease-Free Survival
  • Female
  • Gastrectomy / methods*
  • Humans
  • Kaplan-Meier Estimate
  • Laparoscopy*
  • Male
  • Middle Aged
  • Neoadjuvant Therapy / methods*
  • Patient Selection
  • Research Design
  • Serous Membrane / pathology
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / surgery*