metastatic colorectal cancer
Conditions
Sponsors
Teikyo University Chiba Medical Center
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 metatatic 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) atient 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 haemoglobin concentorarion >=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 NonHaematotoxicity =<grade1 10) gave written informed consent
Exclusion criteria
Exclusion criteria: 1) contraindications for TAS-102 and BEvacizumab 2) previously received chemotherapy with TAS-102 3) severe drug allergy 4) pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5) patient who has important 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) have pleural effusion and ascitic fluid with the treatment 8) Comorbidity or history of heart failure 9) gastrointestinal ulcer or bleeding 10) previous hemoptysis 11) Peritoneal metastases at image 12) Clinical or radiological evidence of CNS metastases 13) Current or previous (within the last 6 months) history of GI perforation 14) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 15) ongoing treatment with anticoagulant 16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 17) Under coutinuous steroid administration 18) dicision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure, response rate , overall survival | — |
Countries
Japan
Contacts
Public ContactTakeshi Yamada
Nippon medical school hospital Gasroenterological Surgery
Outcome results
None listed