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Japanese Journal of Clinical Oncology Advance Access originally published online on August 24, 2009
Japanese Journal of Clinical Oncology 2009 39(10):686-689; doi:10.1093/jjco/hyp078
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© The Author (2009). Published by Oxford University Press
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.5/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

A Phase II Trial of Combined Treatment of Endoscopic Mucosal Resection and Chemoradiotherapy for Clinical Stage I Esophageal Carcinoma: Japan Clinical Oncology Group Study JCOG0508

Yukinori Kurokawa1,2, Manabu Muto3, Keiko Minashi4, Narikazu Boku5, Haruhiko Fukuda1 for the Gastrointestinal Oncology Study Group of Japan Clinical Oncology Group (JCOG)

1 Japan Clinical Oncology Group Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo
2 Department of Surgery, Osaka National Hospital, Osaka
3 Department of Gastroenterology, Kyoto University, Kyoto
4 Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba
5 Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan

For reprints and all correspondence: Manabu Muto, Department of Gastroenterology, Kyoto University, Kyoto, Japan. E-mail: mmuto{at}kuhp.kyoto-u.ac.jp

Received December 23, 2008; accepted June 7, 2009

Standard treatment for clinical stage I esophageal cancer with submucosal invasion (T1b) has been surgical resection. We conducted a Phase II trial to evaluate the efficacy and the safety of combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy for clinical stage I (T1b) esophageal cancer. Patients diagnosed as having clinical stage I (T1b) esophageal cancer which is considered to be resectable by EMR are eligible. When pathological examination of the EMR specimen confirms T1b tumor with negative or positive resection margin, the patient undergoes chemoradiotherapy. The study continues until 82 patients with T1b tumor with negative resection margin are enrolled from 20 institutions. The primary endpoint is 3-year overall survival (OS) in pT1b cases with negative resection margin. The secondary endpoints are 3-year OS and progression-free survival in all eligible cases, OS in pT1a-MM cases with margin-negative, complications of EMR and adverse events of chemoradiotherapy. The data from this trial will be expected to provide a non-surgical treatment option to the patients with clinical stage I (T1b) esophageal cancer.

Key Words: superficial esophageal cancer • endoscopic mucosal resection • chemoradiotherapy


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