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Japanese Journal of Clinical Oncology Advance Access originally published online on April 23, 2009
Japanese Journal of Clinical Oncology 2009 39(6):406-409; doi:10.1093/jjco/hyp035
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© The Author (2009). Published by Oxford University Press. All rights reserved

A Randomized Phase II/III Trial Comparing Hepatectomy Followed by mFOLFOX6 with Hepatectomy Alone as Treatment for Liver Metastasis from Colorectal Cancer: Japan Clinical Oncology Group Study JCOG0603

Yukihide Kanemitsu1, Tomoyuki Kato2, Yasuhiro Shimizu1, Yoshitaka Inaba3, Yasuhiro Shimada4, Kenichi Nakamura5, Akihiro Sato6, Yoshihiro Moriya7 for the Colorectal Cancer Study Group (CCSG) of Japan Clinical Oncology Group

1 Department of Gastroenterological Surgery, Aichi Cancer Center Hospital
2 Department of Surgery, Kamiiida Daiichi General Hospital
3 Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya
4 Department of Gastrointestinal Oncology Division, National Cancer Center Hospital
5 JCOG Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo
6 Research Center for Innovative Oncology, National Cancer Center Hospital East, Kashiwa, Chiba
7 Colorectal Surgery Division, National Cancer Center Hospital, Tokyo, Japan

For reprints and all correspondence: Yukihide Kanemitsu, Department of Gastroenterological Surgery, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan. E-mail: ykanemit{at}aichi-cc.jp

Received October 22, 2008; accepted March 15, 2009

A randomized controlled trial is being conducted in Japan to compare hepatectomy alone with hepatectomy followed by adjuvant chemotherapy as treatment in patients with curatively resected liver metastases from colorectal cancer to improve survival with intensive chemotherapy. Between 42 and 70 days after liver resection, patients are randomly assigned to either hepatectomy alone or hepatectomy followed by 12 cycles of modified FOLFOX6 (mFOLFOX6) regimen. A total of 300 patients (including 78 patients in Phase II) will be accrued from 38 institutions within 3 years. The primary endpoint is treatment compliance at nine courses of mFOLFOX6 regimen in Phase II and disease-free survival in Phase III. The secondary endpoints are overall survival, incidence of adverse events and patterns of recurrence.

Key Words: colorectal cancer • liver metastases • randomized controlled trial • mFOLFOX6


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