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Japanese Journal of Clinical Oncology Advance Access published online on September 4, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp100
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© The Author (2009). Published by Oxford University Press. All rights reserved

Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy: A Placebo-controlled Double-blind Randomized Phase II Study (the GONE Study)

Toru Kono1{dagger}, Hideyuki Mishima2,{dagger}, Mitsuo Shimada3, Satoshi Morita4, Junichi Sakamoto5 for the GONE investigators

1 Division of Gastroenterologic and General Surgery, Department of Surgery, Asahikawa Medical College, Hokkaido
2 Department of Gastroenterological Surgery, Osaka National Hospital, Osaka
3 Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School of Medicine, Tokushima
4 Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Kanagawa
5 Program in Health and Community Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan

For reprints and all correspondence: Toru Kono, Division of Gastroenterologic and General Surgery, Department of Surgery, Asahikawa Medical College, 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510, Japan. E-mail: kono{at}asahikawa-med.ac.jp

Received May 25, 2009; accepted July 22, 2009

We conducted a controlled double-blind randomized study in patients with advanced/recurrent colorectal cancer to investigate the efficacy of Goshajinkigan (GJG) for peripheral neurotoxicity induced by FOLFOX therapy. The primary endpoint is the incidence of peripheral neurotoxicity ≥Grade 2 after eight cycles of chemotherapy. The secondary endpoints are the incidence of peripheral neurotoxicity of each grade after each cycle, the psychometric properties of the FACT/GOG-Ntx, time to occurrence of neurotoxicity, time to treatment failure, progression-free survival, response rate and toxicity. Eighty patients are required in the study (40 patients per group).

Key Words: colorectal cancer • Japanese herbal medicine • oxaliplatin • Goshajinkigan • neurotoxicity

{dagger} These authors contributed equally to this work.


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