Colorectal Cancer
Conditions
Interventions
L-OHP 85mg/m^2 day1 Infusional 5-FU 2400mg/m^2 46hours l-LV 200mg/m^2 day1 Bmab 5mg/kg day1 every 2 weeks At first cycle, 5-FU concentrations are monitored. After second cycle, 5-FU are adminis
Sponsors
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2)No prior chemotherapy for metastatic disease.(Recurrence after 24 weeks of adjuvant therapy is registered) 3)With central venous infusion and infusion pump. 4)Measurable lesion based on RECIST ver1.1. 5)PS(ECOG) 0-1. 6)Age of 20 years or older. 7)A life expectancy of more than 12 weeks. 8)No severe organ failure: and suitable results of all laboratory test performed within 14 days before enrollment. ---WBC >= 3,000/mm^3, <= 12,000/mm^3 ---Neutrophil count >= 1,000/mm^3 ---Plt >= 100,000/mm^3 ---AST(GOT) and ALT(GPT) <= ULN x 2.5 (the patient has liver metastasis: <= ULN x 5) ---T-Bil <= ULN x 1.5 ---Cr <= ULN x 1.5 ---PT-INR <= 1.5 9) Written informed consent will be obtained from each patient before enrollment.
Exclusion criteria
Exclusion criteria: 1)Blood transfusion or administration of blood products or hemopoietic factors within 7 days before enrollment. 2)A history of serious drug hypersensitivity. 3)Serious sensory abnormality or dysesthesia with associated dysfunction. 4)Surgery, biopsy specimen with section or sutures within the past 2 weeks. 5)Serious heart disease. 6)Bleeding, bleeding tendency, coagulopathy, coagulation factor abnormality 7)History of GI perforation within the past one year. 8)Metachronous double cancer within the past 5 years 9)Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure ) 10)Uncontrolled effusion(peritoneal , pleural, cardiac effusion) 11)Brain metastasis 12)With infection or febrile patients. 13)Serious diarrhea. 14)Women who are pregnant, lactating, or wish to become pregnant. 15)Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Examination of 5-FU concentration in plasma 2)Relative dose intensity of oxaliplatin 3)Disease control rate 4)Time to treatment failure 5)Progression free survival 6)Overall survival 7)Resection rate 8)Adverse event | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical research Information Network (ECRIN) ECRIN Data Center
Outcome results
None listed