Age
Item
1. age ≥ 18 and ≤ 75 years;
boolean
C0001779 (UMLS CUI [1])
Primary tumor Radical excision | Adenocarcinoma of large intestine
Item
2. primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma;
boolean
C0677930 (UMLS CUI [1,1])
C0184918 (UMLS CUI [1,2])
C1319315 (UMLS CUI [2])
Secondary malignant neoplasm of liver Synchronous unresectable
Item
3. together with clinical or radiological evidence of first occurrence of non-resectable synchronous liver-only metastases
boolean
C0494165 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
Epidermal Growth Factor Receptor Expression Neoplasm Evidence of | KRAS gene Wild Type
Item
4. with evidence of tumor egfr expression and kras gene wild-type status;
boolean
C0034802 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C1537502 (UMLS CUI [2,1])
C1883559 (UMLS CUI [2,2])
Measurable Disease Quantity
Item
5. with one measurable tumor.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
6. performance status (ecog) 0~1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. a life expectancy of ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
8. adequate hematological function: neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hb ≥9g/dl (within 1 week prior to randomization)
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Renal function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
9. adequate hepatic and renal function: serum bilirubin≤1.5 x upper limit of normal (uln), alkaline phosphatase ≤5x uln, and serum transaminase (either ast or alt) ≤ 5 x uln(within 1 week prior to randomization);
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
Informed Consent
Item
10. written informed consent for participation in the trial.
boolean
C0021430 (UMLS CUI [1])
Targeted Therapy Secondary malignant neoplasm of liver Colorectal | Chemotherapy Secondary malignant neoplasm of liver Colorectal | Therapeutic radiology procedure Secondary malignant neoplasm of liver Colorectal | Therapeutic Intervention Secondary malignant neoplasm of liver Colorectal
Item
1. previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
boolean
C2985566 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
C0555952 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0494165 (UMLS CUI [2,2])
C0555952 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
C0555952 (UMLS CUI [3,3])
C0808232 (UMLS CUI [4,1])
C0494165 (UMLS CUI [4,2])
C0555952 (UMLS CUI [4,3])
Neoplasm Metastasis Extrahepatic | Neoplasm Metastasis Extrahepatic Suspected
Item
2. known or suspected extrahepatic metastases.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Hypersensitivity Investigational therapy Component
Item
3. patients with known hypersensitivity reactions to any of the components of the study treatments.
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Study Subject Participation Status | Cetuximab Possible
Item
4. having previously participated in a study which included a possibility of being allocated to cetuximab therapy (whether or not the patient actually received cetuximab)
boolean
C2348568 (UMLS CUI [1])
C0995188 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Coronary Artery Disease | Myocardial Infarction | Left ventricular ejection fraction Decrease
Item
5. clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (lvef) below the institutional range of normal
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0428772 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
Intestinal Obstruction | Intestinal Obstruction Subacute
Item
6. acute or sub-acute intestinal occlusion
boolean
C0021843 (UMLS CUI [1])
C0021843 (UMLS CUI [2,1])
C0205365 (UMLS CUI [2,2])
Pregnancy Serum pregnancy test | Pregnancy Urine human chorionic gonadotropin measurement | Breast Feeding
Item
7. pregnancy (absence confirmed by serum/urine β-hcg) or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0430064 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C2188702 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
8. other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Substance Use Disorders
Item
9. known drug abuse/ alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Incapacity Legal | Legal capacity Limited
Item
10. legal incapacity or limited legal capacity
boolean
C3176592 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Peripheral Neuropathy Pre-existing
Item
11. pre-existing peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])