JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo.
Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa.
Jpn J Clin Oncol. 2020 Oct 22;50(11):1321-1324. doi: 10.1093/jjco/hyaa113.
Gastrectomy with omentectomy and D2 lymph node dissection is the current standard procedure for locally advanced gastric cancer. However, some retrospective studies have reported that omentectomy increased post-operative abdominal complications but provided no survival advantage over omentum preservation. Therefore, we plan a randomized controlled phase III trial to confirm the non-inferiority of omentum preservation compared with omentectomy in patients with cT3 (SS) or cT4a (SE) gastric cancer. A total of 1050 patients will be enrolled from 62 institutions over a period of 6.5 years. The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000036253.
胃切除术联合网膜切除术和 D2 淋巴结清扫术是目前局部进展期胃癌的标准治疗方法。然而，一些回顾性研究报道网膜切除术增加了术后腹部并发症，但与保留网膜相比，并没有生存优势。因此，我们计划进行一项随机对照 III 期临床试验，以确认在 cT3（SS）或 cT4a（SE）胃癌患者中，保留网膜与网膜切除术相比非劣效性。这项试验将在 6.5 年内从 62 个机构招募 1050 名患者。主要终点是无复发生存期，次要终点是总生存期、出血量、手术时间和不良事件。这项试验已在 UMIN 临床试验注册中心注册，注册号为 UMIN000036253。
