Eligibility Liver Metastases NCT01631539

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StudyEvent: Eligibility
1. Eligibility Liver Metastases NCT01631539

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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Eligibility Liver Metastases NCT01631539