metastatic colorectal cancer
Conditions
Sponsors
Tokushima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patient who has histologically or cytologically confirmed colorectal adenocarcinoma 2) patient who has confirmed K-RAS status of colorectal cancer 3) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them 4) patient who has at least one measurable lesion in imaging study within 28 days before enrollment(not essential criteria) 5) patient who is 70 years or older, and considered to be intorelant to other strong chemotherapeutic regimens after one or more strong regimens 6) patient with an ECOG Performance Status of between 0 and 2 7) patient with ability to tolerate oral drug administration 8) patient who has adequate main organ functions in tests within 14 days before enrollment neutrophil count >=1,500/mm3 platelet count >=100,000/mm3 haemoglobin concentorarion >=9.0 g/dL serum total bilirubin level <=1.5 mg/dL serum AST and ALT levels <=100 U/L serum creatinine <=1.5 mg/dL 9) patient who has a life expectancy of at least 3 months 10) written informed consent got from the patient
Exclusion criteria
Exclusion criteria: 1) patient who had previously received chemotherapy with TAS-102 2) patient who has history of hemoptysis(>=25mL, fresh blood) 3) patient with other active malignancies 4) patient with symptomatic brain metastasis 5) patients with serious pleural effusion, ascites or pericardial effusion 6) patients with active infection 7) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 8) 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.) 9) patient with non-healing wound or traumatic bone fracture 10) patient with bleeding disorders or current use of anticoagulant 11) patient with severe drug allergy 12) male patient who hoping partner's pregnancy 13) patient who has at least either one of HIV antibody, HBs antigen, or HCV antibody 14) patient who given a dicision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, response rate , disease control rate, relative dose intensity, frequency and grade of adverse events | — |
Countries
Japan
Contacts
Public ContactTetsuji Takayama
Institute of Biomedical Sciences, Tokushima University Graduate School Gastroenterology and Oncology
Outcome results
None listed