Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study - Goshajinkigan Effect for oxaliplatin Neurotoxicity Inhibition USing mFOLFOX6 regimen(GENIUS)

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University0 个研究点目标入组 310 人开始时间: 2010年10月1日最近更新: 2023年10月17日

适应症

试验速览

Int J Clin Oncol. 2015 Jan 28. [Epub ahead of print] PMID:25627820[PubMed - as supplied by publisher] Related citations

•1)transfusion, G-CSF etc. within 7days 2)severe allergic reaction 3)peripheral neuropthy 4)Simultaneous or metachronous double cancers 5)Active infectious disease 6)Severe mental disease 7)Grade2+, diarrhea 8)systemic administration of corticosteroids 9)Pregnant or lactating women or women of childbearing potential 10)Severe comorbidity (interstitial peumonitis, lung fibrosis, paralytic ileus, mechanical ileus, uncontrollable diabetes, liver cirosis, chronic hepatitis, career with hepatitis B/C, renal failure, heart failure, uncontrollable hypertension, unstable angina etc) 11)AMI within 6 months 12)History of transplantation 13)Preoperative therapy for CRC 14)History of colostomy 15)Unhealing of post-operative complication 16)Gashajinkigan, or drug for neuropathy 17)Any other cases who are regarded as inadequate for study enrollment by the investigator

发起方

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University