Metastatic Colorectal Cancer
Conditions
Interventions
Chemotherapy regimen mFOLFOX6 +Cetuximab Cetuximab 500mg/m2/biweekly Oxaliplatin 85mg/m2/biweekly l-LV 200mg/m2/biweekly 5-FU/bolus 40mg/m2/biweekly 5-FU/infusional 240
Sponsors
Epidemiological and Clinical Research Information Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed metastatic colorectal cancer (mCRC) 2) Inoperable mCRC 3) KRAS mutations (codons 12/13) were not detected 4) Presence of at least one measurable lesion using the RECIST (ver1.1 guidelines) 5) No prior chemotherapy for mCRC 6) Relapse over 24 weeks of adjuvant chemotherapy with Oxialiplatin 7) Age over 20 years 8) ECOG PS 0,1 9) Adequate organ functions 10)Written informed consent
Exclusion criteria
Exclusion criteria: No serious myelosuppression 2)No sensory alteration or paresthesia interfering with function 3)No mental disease or neurovascular disease 4)No radiotherapy to target lesion 5)No severe stenosis by primary lesion 6)No hypersensitivity for test drugs 7)No serious infection 8)No cardiovascular disease, complication 9)No brain metastasis, 10)No large quantity of abdominal or pleural effusion 11)No diarrhea, 12)No active double cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Early tumor shrinkage (at week 8) 2) Response rate in target organ 3) Desease control rate 4) Progression free survival 5) Overall survival 6) Efficacy and safety of 5-FU/LV/Cetuximab 7) Safety 8) Ro resection rate | — |
Countries
Japan
Outcome results
None listed