metastatic colorectal cancer
Conditions
Interventions
Liquid biopsy to detect RAS mutation
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven colorectal cancer 2)RAS wild type 3)patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s) 4)No treatment history for metastatic colorectal cancer 5)20<= and 80>= years old 6)ECOG performance status of 0 or 1 7)With measurable lesions according 8)well dietary intake 9)a life expectancy of at least 3 months 10)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 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 11)gave written informed consent
Exclusion criteria
Exclusion criteria: 1)contraindications for EGFR blockades 2)previously received chemotherapy with EGFR blockades 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)Clinical or radiological evidence of CNS metastases 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 |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of Early tumor shrinkage Progression free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactTakeshi Yamada
Nippon Medical School Digestive Surgery
Outcome results
None listed