Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity

INTERVENTION: During XELOX regimen, Kampo medicine is administered as follows: Level 1(TJ‐18 7.5g, TJ‐3023 0g), Level 2(TJ‐18 7.5g, TJ‐3023 1.5g), Level 3(TJ‐18 7.5g, TJ‐3023 3.0g) CONDITION: colorectal cancer PRIMARY OUTCOME: Decision of DLT, MTD, RD of Kampo medicine (TJ‐3023, TJ‐18) SECONDARY OUTCOME: Decision of RDI of oxaliplatin, Examination for oxaliplatin‐induced peripheral neurotoxicity (neurosensory test, QOL) INCLUSION CRITERIA: 1.histopathological colorectal cancer 2.stage II or III 3.adjuvant chemotherapy using oxaliplatin 4. more than 20 yeras old 5. ECOG Performance Status 0‐1 6.no organ failure 7.no chemotherapy 8.informed consent