Metastatic colorectal cancer
Conditions
Interventions
Sponsors
Yodogawa Christian Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed colorectal cancer (adenocarcinoma) 2) Unrecetable recurrent or metastatic colorectal cancer 3) Age 20<= 80> 4) PS(ECOG) 0 or 1 5) Presence of tumor region assessed by image test 30 days before the registry (measureable region is not necessary) 6) No prior chemotherapy and radiotherapy 7) Capability of oral intake 8) Sufficient organ functions WBC>=3000/mm3 and <=12000/mm3 Neutrophils>=1500/mm3 Platelets>=100000/mm3 Hemoglobin>=9.0g/dL Platelets>=100000/mm3 Total bilirubin<2.0mg/dL AST<=100IU/L ALT<=100IU/L Creatinine Clearance>=60mL/min 9) Expected life over 90 days 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Medical history of severe anaphylaxis or allergia to any drug 2) Pregnant or lactating woman at any time during study. Men of the fertility hope. 3) Serious infection 4) Severe complications 5) Severe cardiac disease 6) Neuropathy 7) Severe diarrhea 8) Massive pleural or abdominal effusion 9) High grade stenosis at the primary tumor 10) Presence of peritoneal dissemination or peritoneal tuberosity assessed by image test 11) Brain metastasis 12) Double cancer 13) Prior adjuvant chemotherapy with oxaliplatin containing regimen 14) Systemic administration of corticosteroids 15) Patients who are judged inappropriate for the entry into the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and grade of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of disease control, Tumor response rate, Overall survival, Progression-free survival, Disease control rate, Time to treatment failure, R0 resection rate, Compliance | — |
Countries
Japan
Outcome results
None listed