A multicenter non-randomized phase III study of sentinel node navigation surgery for early gastric cancer

Satoshi Kamiya, Hiroya Takeuchi, Kazumasa Fukuda, Hirofumi Kawakubo, Naoto Takahashi, Norio Mitsumori, Masanori Terashima, Hironori Tsujimoto, Shinichi Kinami, Shoji Natsugoe, Masaki Ohi, Shinichi Kadoya, Sachio Fushida, Hideki Hayashi, Kazuhito Nabeshima, Junichi Sakamoto, Satoru Matsuda, Shuhei Mayanagi, Tomoyuki Irino, Yasunori SatoYuko Kitagawa

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)305-309
Number of pages5
JournalJapanese journal of clinical oncology
Volume51
Issue number2
DOIs
Publication statusPublished - 2021 Feb 8

Keywords

  • clinical trial
  • phase III
  • precision medicine
  • sentinel lymph node
  • stomach neoplasms

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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