A Phase III Study of Laparoscopy-assisted Versus Open Distal Gastrectomy with Nodal Dissection for Clinical Stage IA/IB Gastric Cancer (JCOG0912)

作者：Nakamura Kenichi; Katai Hitoshi^*; Mizusawa Junki; Yoshikawa Takaki; Ando Masahiko; Terashima Masanori; Ito Seiji; Takagi Masakazu; Takagane Akinori; Ninomiya Motoki; Fukushima Norimasa; Sasako Mitsuru

来源：Japanese Journal of Clinical Oncology, 2013, 43(3): 324-327.

DOI：10.1093/jjco/hys220

• gastric cancer
• laparoscopic surgery
• gastrectomy
• clinical trial
• Phase III

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.

• 出版日期2013-3