KRAS wild-type metastatic colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histological confirmation of colorectal cancer. 2)Unresectable relapse or metastatic colorectal cancer. 3) Measurable or evaluable disease (RECIST ver.1.1.) 4)KRAS Wild-type 5)No prior chemotherapy except adjuvant chemotherapy if completed more than 6months (L-OHP base: more than 12months) prior to enrollment. 6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 7) Age of 20 years or older. 8) Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i WBC 3,000/mm3 >= and =<12,000/mm3 ii Neurtophils>=1500/mm3 iii Platelets>=100,000/mm3 iv Hemoglobin>=9.0g/dl v AST and ALT =<upper limit of normal (ULN)*2.5 (=<ULN*5 in case of liver metastasis) vi Total bilirubin =<upper limit of normal (ULN)*2.0 vii Serum creatinine =<upper limit of normal (ULN)*1.25 9)Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Peripheral sensory neuropathy (CTCAEv4.0;>=Grade1). 2) Histroy of the serious hypersensitivity for drugs. 3) Active infection. 4) Complications (Evidence of interstinal lung disease, emphysema, pulmonary fibrosis,paralytic or mechanical bowel obstruction, uncontrolled hypertension,uncontrolled diabetes mellitus,cirrhosis, active cardiovascular disease, or past current history (within 3 months) of myocardial infarction, uncontrolled angina pectoris or arrhythmia. 5) Multiple primary cancer within 5years. 6) Need to drain pleural effusion, ascites or pericardial effusion. 7) Uncontrolled diarrhea. 8) Radiological evidence of brain metastasis. 9) Clinically significant mental or psychological disease. 10) Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall Survival Adverse Effect Resection rate of metastatic resion R0 resection rate | — |
Countries
Japan
Contacts
Gunma University Department of general surgical science