Preventive effect of goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: a placebo-controlled double-blind randomized phase II study (the GONE Study)

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 > or = 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).