Eligibility Colorectal Cancer NCT00569699

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StudyEvent: Eligibility
1. Eligibility Colorectal Cancer NCT00569699

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Colorectal Carcinoma | Disease Inoperable | Disease Advanced Locally | Neoplasm Metastasis | Disease Inappropriate Curative treatment

Item

1. histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy

boolean

C0009402 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C1273390 (UMLS CUI [5,3])

Measurable Disease | Disease Assessment Possible

Item

2. measurable disease or non-measurable but assessable disease according to the response evaluation criteria in solid tumors (recist)

boolean

C1513041 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])

Therapeutic radiology procedure Absent | Chemotherapy Absent | Adjuvant Chemotherapy Postoperative Discontinued | Recurrent disease

Item

3. patients with no previous treatment (radiotherapy or chemotherapy). patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.

boolean

C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4])

Folinic Acid-Fluorouracil-Irinotecan Regimen | FOLFOX Regimen

Item

4. treatment with folfiri and folfox is not indicated.

boolean

C1880658 (UMLS CUI [1])
C0392943 (UMLS CUI [2])

Age

Item

5. age >65 years

boolean

C0001779 (UMLS CUI [1])

Life Expectancy

Item

6. life expectancy of at least 3 months

boolean

C0023671 (UMLS CUI [1])

ECOG performance status

Item

7. ecog ps of 0, 1, or 2

boolean

C1520224 (UMLS CUI [1])

Organ Major function

Item

8. adequate function of major organs as defined below:

boolean

C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])

Hemoglobin measurement

Item

1. hemoglobin >9.0 g/dl

boolean

C0518015 (UMLS CUI [1])

White Blood Cell Count procedure

Item

2. white blood cell count >3,500/mm3, <12,000/mm3

boolean

C0023508 (UMLS CUI [1])

Neutrophil count

Item

3. neutrophil count >1,500/mm3

boolean

C0200633 (UMLS CUI [1])

Platelet Count measurement

Item

4. platelet count >100,000/mm3

boolean

C0032181 (UMLS CUI [1])

Serum total bilirubin measurement

Item

5. total bilirubin <1.5 mg/dl

boolean

C1278039 (UMLS CUI [1])

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

Item

6. ast and alt <100 u/l (<200 u/l in patients with liver metastasis)

boolean

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

Creatinine measurement, serum

Item

7. serum creatinine <1.2 mg/dl

boolean

C0201976 (UMLS CUI [1])

Estimation of creatinine clearance by Cockcroft-Gault formula

Item

8. creatinine clearance estimate by the cockcroft-gault method >50 ml/min

boolean

C2711451 (UMLS CUI [1])

Able to swallow capsules

Item

9. able to take capsules orally.

boolean

C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])

Electrocardiogram abnormal Absent

Item

10. no electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.

boolean

C0522055 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])

Informed Consent

Item

11. voluntary written informed consent.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Drug Allergy Serious | Drug Allergy

Item

1. serious drug hypersensitivity or a history of drug allergy

boolean

C0013182 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])

Malignant Neoplasm Double

Item

2. active double cancer

boolean

C0006826 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])

Communicable Diseases | Fever

Item

3. active infections (e.g., patients with pyrexia of 38℃ or higher)

boolean

C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])

Uncontrolled hypertension

Item

4. uncontrolled hypertension

boolean

C1868885 (UMLS CUI [1])

Item

5. serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)

boolean

C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2])
C0206061 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C0035078 (UMLS CUI [5])
C0085605 (UMLS CUI [6])
C0554876 (UMLS CUI [7])

Ascites Moderate | Ascites Severe | Pleural effusion Treatment required for

Item

6. moderate or severe ascites or pleural effusion requiring treatment

boolean

C0003962 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])

Watery diarrhoea

Item

7. watery diarrhea

boolean

C0239182 (UMLS CUI [1])

Flucytosine

Item

8. treatment with flucytosine

boolean

C0016278 (UMLS CUI [1])

CNS metastases

Item

9. metastasis to the cns

boolean

C0686377 (UMLS CUI [1])

Pregnancy | Possible pregnancy | Pregnancy, Planned | Breast Feeding | Gender Trying to conceive

Item

10. pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. men who are currently attempting to conceive children.

boolean

C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0420843 (UMLS CUI [5,2])

Mental disorders Severe

Item

11. severe mental disorder

boolean

C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

Steroids

Item

12. continuous treatment with steroids

boolean

C0038317 (UMLS CUI [1])

Urine dipstick test Proteinuria

Item

13. urine dipstick for proteinuria should be <2+

boolean

C0430370 (UMLS CUI [1,1])
C0033687 (UMLS CUI [1,2])

Thrombosis | Cerebral Infarction | Myocardial Infarction | Pulmonary Embolism

Item

14. thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism

boolean

C0040053 (UMLS CUI [1])
C0007785 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0034065 (UMLS CUI [4])

Major surgery | Incisional biopsy | Traumatic injury

Item

15. major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks

boolean

C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])

Aspirin U/day Long-term

Item

16. long-term daily treatment with aspirin (>325 mg/day)

boolean

C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])

Bleeding tendency Hereditary | Blood Coagulation Disorder Bleeding Risk

Item

17. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding

boolean

C1458140 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C3251812 (UMLS CUI [2,2])

Study Subject Participation Status Ineligible | Patient safety At risk

Item

18. judged ineligible for participation in the study by the investigator for safety reasons.

boolean

C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C1113679 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])

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Eligibility Colorectal Cancer NCT00569699