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Japanese Journal of Clinical Oncology
Year: 2009  |  Volume: 39  |  Issue: 12  |  Page No.: 847 - 849

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

T Kono, H Mishima, M Shimada, S Morita, J Sakamoto and for the GONE investigators    

Abstract:

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).

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