Adenocarcinoma of large intestine KRAS wild-type TNM clinical staging | Secondary malignant neoplasm of liver Unresectable
Item
1. confirmed diagnosis of stage iv kras wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
boolean
C1319315 (UMLS CUI [1,1])
C4684887 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0494165 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Primary Neoplasm Complete excision | Residual Tumor Absent
Item
2. primary tumour has been treated with complete surgical resection without evidence of residual tumour
boolean
C0677930 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C0543478 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
3. patients must have at least 1 measurable lesion (recist criteria)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
4. performance status ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. aged ≥18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Prior Chemotherapy Absent Neoplasm Metastasis
Item
7. no prior chemotherapy for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Hematologic function | White Blood Cell Count procedure | Platelet Count measurement
Item
8. hematologic function: wbc ≥ 3.0 x 10*9/l, platelets ≥ 100 x10*9/l
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Organ function
Item
9. adequate organ function as measured by:
boolean
C0678852 (UMLS CUI [1])
Serum creatinine raised
Item
serum creatinine £ 1.5 x upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased
Item
serum transaminases (ast & alt) £ 5 x uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
SERUM TOTAL BILIRUBIN ELEVATED
Item
bilirubin> 1.5 times the upper limit of the normal range
boolean
C0595866 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
10. women of child bearing potential and fertile men are required to use effective contraception (negative βhcg for women of child-bearing age)
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430060 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Informed Consent
Item
11. signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Main portal vein patent
Item
12. patients with patent main portal vein
boolean
C1183135 (UMLS CUI [1,1])
C0175566 (UMLS CUI [1,2])
Liver Involvement Maximum
Item
13. maximum liver involvement ≤60%
boolean
C0023884 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
CNS metastases
Item
1. presence of cns metastases
boolean
C0686377 (UMLS CUI [1])
Medical contraindication FU-LV Regimen | Medical contraindication irinotecan | Medical contraindication cetuximab
Item
2. contraindications to fu/lv, irinotecan or cetuximab
boolean
C1301624 (UMLS CUI [1,1])
C1880814 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0123931 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0995188 (UMLS CUI [3,2])
Bacterial Infections | Virus Diseases | Mycoses
Item
3. active bacterial, viral or fungal infection within 72 hours of study entry
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
4. women who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contrast media allergy | Severe allergy Investigational New Drugs
Item
5. allergy to contrast media or history of severe hypersensitivity to study drugs.
boolean
C0570562 (UMLS CUI [1])
C2945656 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
6. presence of another concurrent malignancy. prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Medical contraindication Hepatic embolization
Item
7. any contraindication for hepatic embolization procedures:
boolean
C1301624 (UMLS CUI [1,1])
C0744813 (UMLS CUI [1,2])
Portosystemic shunt
Item
porto-systemic shunt
boolean
C0948900 (UMLS CUI [1])
Hepatofugal flow
Item
hepatofugal blood flow
boolean
C4086746 (UMLS CUI [1])
Atheromatosis Severe
Item
severe atheromatosis
boolean
C0004153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Catheterization hepatic artery | Peripheral Vascular Disease Severe Excludes Catheterization
Item
8. contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
boolean
C1301624 (UMLS CUI [1,1])
C4031927 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0007430 (UMLS CUI [2,4])
Other medical condition Study Subject Participation Status At risk | Other medical condition Excludes Chemoembolization | Other medical condition Interferes with Study Subject Participation Status | Surgical aspects Study Subject Participation Status At risk | Surgical aspects Exclude Chemoembolization | Surgical aspects Interfere with Study Subject Participation Status | Pharmacotherapy Study Subject Participation Status At risk | Pharmacotherapy Excludes Chemoembolization | Pharmacotherapy Interferes with Study Subject Participation Status | Therapeutic procedure Study Subject Participation Status At risk | Therapeutic procedure Excludes Chemoembolization | Therapeutic procedure Interferes with Study Subject Participation Status
Item
9. other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0796679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0038895 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0038895 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0796679 (UMLS CUI [5,3])
C0038895 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0013216 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0013216 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
C0796679 (UMLS CUI [8,3])
C0013216 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C0087111 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C0087111 (UMLS CUI [11,1])
C0332196 (UMLS CUI [11,2])
C0796679 (UMLS CUI [11,3])
C0087111 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C2348568 (UMLS CUI [12,3])