colorectal cancer
Conditions
Interventions
Irinotecan 150 mg/m2/biweekly div l-LV 200mg/m2/biweekly div 5-FU/bolus 400mg/m2/biweekly div (bolus) 5-FU/infusional 2,400mg/m2/biweekly div Panitumumab 6mg/kg/biweekly div or
Sponsors
Epidemiological and Clinical research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed colorectal cancer 2)KRAS wild type 3)Measurable lesions in RECIST V1.1 4)One prior first line chemotherapy consisting of fluoropyrimidine and oxaliplatin with or without bevacizumab. 5)Age, 20 years old and above 6)ECOG performance status of 0-2 7)Sufficient organ functions a)WBC=>3000/mm3 b)Neutrophil=>1500/mm3 c)Platelet count=>75000/mm3 d)Hemoglobin=>8.0g/dL e)Total bilirubin<=2*ULN f)AST ALT<= 100 lU/L(Liver Met; AST, ALT<=199lU/L) g)Creatinine<=1.5*ULN h)<S-1> Ccr=>50mL/min i)Urine protein<=1+ 8)Life expectancy of at least 8 week 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Brain metastasis (symptomatic) 2) Diarrhea 3) Intestinal paralysis or obstruction 4) With infectious diseases or febrile condition 5) With severe pulmonary diseases (interstitial pneumonitis, pulmonary fibrosis) 6) With severe diseases ( DM, heart failure, renal failure, liver dysfunction) 7) Pregnant or possibly pregnant, and nursing women 8) Carcinomatous menigitis, history of mental or cerebrovascular disorder 9) With grade 3 peripheral neuropathy 10) Administration of contraindicative medicines 11) History of administration of antagonisms to EGF signal 12) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Overall survival Disease control rate Adverse events Biomarkers on clinical examination data | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical research Information Network (ECRIN) Data Center
Outcome results
None listed