Eligibility Colon Cancer NCT00890188

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StudyEvent: Eligibility
1. Eligibility Colon Cancer NCT00890188

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Colorectal Carcinoma

Item

histologically or cytologically confirmed colorectal carcinoma

boolean

C0009402 (UMLS CUI [1])

Chemotherapy Containing Oxaliplatin Quantity | Unwilling Chemotherapy Containing Irinotecan

Item

patients must have received at least one oxaliplatin-contained chemotherapy before the study and did not want to receive or tolerate irinotecan- contained chemotherapy

boolean

C0392920 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0069717 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0558080 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0123931 (UMLS CUI [2,4])

Measurable Disease Quantity | Measurement Dimensions Quantity | Measurable Disease Size CT | Measurable Disease Size Spiral CT

Item

presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as 20 mm with conventional ct or 10 mm with spiral ct scan

boolean

C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0242485 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0860888 (UMLS CUI [4,3])

Age | ECOG performance status

Item

age ≥ 18 year, ecog performance status 0, 1, 2, 3

boolean

C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])

White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Item

white blood cell (wbc) ≥ 3,000/mm3, absolute neutrophil count (anc) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 8 mg / dl

boolean

C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])

Creatinine measurement, serum

Item

serum creatinine level 2.0 mg/dl or lower

boolean

C0201976 (UMLS CUI [1])

Serum total bilirubin measurement

Item

serum bilirubin less than 1.5 times the upper limit of normal range (uln)

boolean

C1278039 (UMLS CUI [1])

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Item

alanine aminotransferase (alt) or aspartate aminotransferase (ast) less than 2.5 times the uln if no demonstrable liver metastases or less than 5 times the uln in the presence of liver metastases

boolean

C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])

Immunotherapy | Biological treatment Systemic | Targeted Therapy

Item

require to wait 28 days before entry onto the study after being treated with any immunotherapy, or biologic systemic (including any target therapy)

boolean

C0021083 (UMLS CUI [1])
C1531518 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3])

Informed Consent

Item

written informed consent to participate in the trial

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

CNS metastases

Item

presence of cns metastasis

boolean

C0686377 (UMLS CUI [1])

Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Item

other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])

Prior Therapy

Item

less than 4 weeks since previous treatment

boolean

C1514463 (UMLS CUI [1])

Item

concomitant illness that might be aggregated by chemotherapy. for examples, active, non-controlled infection or other active, non-controlled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, arrhythmia. it depends on investigation's decision.

boolean

C0009488 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0035229 (UMLS CUI [7])
C0003811 (UMLS CUI [8])

Childbearing Potential Contraceptive methods Lacking

Item

women of child-bearing potential without using a reliable and appropriate contraceptive method during study period

boolean

C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])

Neurotoxicity Sensory Pre-existing CTCAE Grades | Neurotoxicity Motor Pre-existing CTCAE Grades | Paresthesia Disabling condition | Loss of motor functions

Item

pre existent sensory or motor neurotoxicity > grade 2 according to national cancer institute (nci) common toxicity criteria (ctc) (disabling paresthesia and/or significant motor loss)

boolean

C0235032 (UMLS CUI [1,1])
C0445254 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0235032 (UMLS CUI [2,1])
C0501384 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
C0030554 (UMLS CUI [3,1])
C4061999 (UMLS CUI [3,2])
C1864672 (UMLS CUI [4])

Chemotherapy | Therapeutic radiology procedure | Therapy, Investigational

Item

patients who are receiving other concomitant chemotherapy, radiotherapy or any other investigational therapy

boolean

C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0949266 (UMLS CUI [3])

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Eligibility Colon Cancer NCT00890188