metastatic colorectal cancer
Conditions
Interventions
Regorafinib: 80mg/body/day, given orally for 7 days. After confirmation of acceptability, daily dosage is escalated to 120mg/body/day and given for 7 days. After confirmation of acceptability again, d
Sponsors
Department of Coloproctological Surgery, Juntendo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven colorectal cancer 2)patient who has unresectable primary tumor or with one or more unresectable metastatic tumor(s) 3)treatment history of two or more regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study 4)20<= and 80>= years old 5)ECOG performance status of 0 or 1 6)With measurable lesions according 7)ability to tolerate oral drug administration 8)a life expectancy of at least 3 months 9)Patient who has adequate main organ functions in tests within 14 days before enrollment leukocyte >=3,500/mm3 neutrophil >=1,500/mm3 platelet >=75,000/mm3 hemoglobin concentration >=8.0 g/dL serum total bilirubin level <=1.5 mg/dL serum creatinine <=1.5 mg/dL serum AST and ALT levels <2.5x Upper limit of normal (ULN). serum creatinine <=1.5 mg/dL Peripheral neuropathy<=grade2 Diarrhea and Non-hematotoxicity =<grade1 10)gave written informed consent
Exclusion criteria
Exclusion criteria: 1)contraindications for Regorafinib 2)previously received chemotherapy with Regorafinib 3)severe drug allergy 4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5)patient who has severe clinical complications (symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 6)other active malignancies 7)severe disorder of liver function 8)Uncontrollable hypertension 9)Severe complication 10)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 11)Under continuous steroid administration 12)decision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Countries
Japan
Contacts
Public ContactTakeshi Yamada
Nippon medical school hospital Digestive Surgery
Outcome results
None listed