A multicenter non-randomized phase III study of sentinel node navigation surgery for early gastric cancer. (5th October 2020)

• Record Type: Journal Article
• Authors: Kamiya, Satoshi; Takeuchi, Hiroya; Fukuda, Kazumasa; Kawakubo, Hirofumi; Takahashi, Naoto; Mitsumori, Norio; Terashima, Masanori; Tsujimoto, Hironori; Kinami, Shinichi; Natsugoe, Shoji; Ohi, Masaki; Kadoya, Shinichi; Fushida, Sachio; Hayashi, Hideki; Nabeshima, Kazuhito; Sakamoto, Junichi; Matsuda, Satoru; Mayanagi, Shuhei; Irino, Tomoyuki; Sato, Yasunori; Kitagawa, Yuko
• Is Part Of: Japanese journal of clinical oncology. Volume 51:Number 2(2021)
• Page Start: 305
• Page End: 309
• Publication Date: 2020-10-05
• Subjects: stomach neoplasms -- sentinel lymph node -- precision medicine -- clinical trial -- phase III; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyaa179
• Languages: English
• ISSNs: 0368-2811

Abstract

Abstract: This prospective multicenter non-randomized phase III study aims to evaluate the long-term outcome of sentinel node navigation surgery for early gastric cancer compared with conventional distal or total gastrectomy. Clinically diagnosed primary T1N0M0 gastric cancer patients with a single lesion (≤40 mm) and without previous endoscopic treatment will be enrolled in this study. Sentinel nodes are identified by dye and radioisotope tracers and are subjected to intraoperative rapid pathology. For patients with negative sentinel node metastasis, individualized surgery consisting of limited stomach resection and sentinel node basin dissection is performed, while standard gastrectomy with D2 lymph node dissection is employed for the positive sentinel node patients. A total of 225 patients will be accrued from 13 hospitals that have experience in sentinel node mapping. The primary endpoint is 5-year relapse-free survival. The secondary endpoints are overall survival, sentinel node detection rate, diagnostic accuracy for sentinel node, distribution of sentinel nodes and metastatic sentinel node/non-sentinel node, and postoperative quality of life. Abstract : This is a multicenter non-randomized phase III study to assess the non-inferiority of the long-term outcome of sentinel node navigation surgery to that of conventional gastrectomy in early gastric cancer.