colorectal cancer
Conditions
Interventions
The initial dosage of Cetuximab assumes it 400mg/ m2. Cetuximab gives the second one week after initial administration, but the dose from the second assumes it 250mg/ m2. mFOLFOX6 repeats the admini
Sponsors
Yokohama City University Hospital Clinical Oncology division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Colorectal cancer histological proven 2)Unresectable liver metastasis more than 5 synchronism liver metastases or more than 5cm tumor size 3)Primary tumor is performed radical excision of; or the case that is available for radical excision in curative hepatectomy by this study and synchronism or heterochrony 4)KRAS wild type of Codon 12 and codon 13 5)A measurable lesion or an evaluable lesion is confirmed with an objectivity document according to RECIST standard 6)No prior chemotherapy for colorectal cancer 7)No prior oxaliplatin and cetuximab or panitumumab 8)More than 20 years old 9)Expect to survive more than 3 months 10)ECOG performance status: 0-1 11)Organs (bone marrow, lung, liver and kidney) failure is not advanced i)Hemoglobin : more than 8.0g/dl ii)Neutrophil count : more than 1,500 / mm3 iii)Platelet : more than 100,000 / mm3 iv)Serum total bilirubin : less than 1.5 mg / dl v)AST,ALT : less than 200 U/l vi)Serum creatinine : less tahn 1.5 mg / dl 12)ECG no abnormalities in 28 days before 13)Informed consent
Exclusion criteria
Exclusion criteria: 1)Severe drug allergy 2)Metastatic focus out of the liver 3)Active double cancer 4)Active infection 5)Intestinal paralysis, intestinal obstruction 6)Severe complications (interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure, it is difficult to control hypertention, diabetes etc.) 7)Pleural effusion, ascites 8)Diarrhea (watery stool) 9)Brain metastases 10)Pregnant and lacting women 11)A bleeding tendency, coagulation disorder or the case with the abnormal clotting factor 12)Mental disorder 13)Patients who receive steroid continuously are excluded 14)Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded 15)History of the organ transplantation to need an immunosuppressive drug 16)The patient that a study responsibility physician judged to be inappropriat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Resection rate of liver metastatis resion R0 liver resection rate Relapse-free survival Overall survival Treatment completion rate | — |
Countries
Japan
Contacts
Public ContactAyumu Goto MD. PhD.
Yokohama City University Hospital Clinical Oncology division
Outcome results
None listed