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Japanese Journal of Clinical Oncology Advance Access originally published online on June 3, 2009
Japanese Journal of Clinical Oncology 2009 39(7):464-466; doi:10.1093/jjco/hyp041
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© The Author (2009). Published by Oxford University Press. All rights reserved

A Phase II Trial of Endoscopic Submucosal Dissection for Mucosal Gastric Cancer: Japan Clinical Oncology Group Study JCOG0607

Yukinori Kurokawa1,4, Noriaki Hasuike2, Hiroyuki Ono2, Narikazu Boku3, Haruhiko Fukuda1 for the Gastrointestinal Oncology Study Group of Japan Clinical Oncology Group (JCOG)

1 Center for Cancer Control and Information Services, National Cancer Center, Tokyo
2 Division of Endoscopy, Shizuoka Cancer Center
3 Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka
4 Department of Surgery, Osaka National Hospital, Osaka, Japan

For reprints and all correspondence: Hiroyuki Ono, Division of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan. E-mail: h.ono{at}scchr.jp

Received March 24, 2009; accepted April 2, 2009

A Phase II trial was started in Japan to evaluate the efficacy and safety of endoscopic submucosal dissection for macroscopic mucosal (cT1a) gastric cancer beyond the present indication described in the Gastric Cancer Treatment Guidelines by the Japan Gastric Cancer Association. Patients with cT1a gastric cancer, which is histologically proven differentiated (intestinal) type adenocarcinoma, are eligible. In this study, the tumor is >2 cm for ulceration (UL)-negative cases or ≤3 cm for UL-positive cases. A total of 330 patients are enrolled from 26 institutions over 2 years. The primary endpoint is the 5-year overall survival (OS). The secondary endpoints are OS in the UL-negative subset and the UL-positive subset, recurrence-free survival (RFS), 5-year RFS with preserved stomach, proportion of en bloc resection, proportion of pathological curative resection and adverse events.

Key Words: clinical trial • endoscopy-upper GI • early gastric cancer


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