Eligibility Non Small Cell Lung Cancer NCT00452075

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StudyEvent: Eligibility
1. Eligibility Non Small Cell Lung Cancer NCT00452075

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Non-small cell lung cancer recurrent TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | NSCLC recurrent Advanced Locally Inoperable | NSCLC metastatic Advanced Locally Inoperable

Item

histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage iiib or stage iv) nsclc.

boolean

C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0278517 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0205187 (UMLS CUI [3,4])
C0278987 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C0205187 (UMLS CUI [4,4])

Chemotherapy naive

Item

chemo-naïve patients.

boolean

C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])

Patients Medically unfit Chemotherapy

Item

patients who are in the investigator's opinion not medically suitable for chemotherapy.

boolean

C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])

Measurable Disease

Item

measurable disease according to the recist criteria.

boolean

C1513041 (UMLS CUI [1])

ECOG performance status

Item

ecog performance status of 0 - 3.

boolean

C1520224 (UMLS CUI [1])

Life Expectancy

Item

life expectancy of at least 12 weeks.

boolean

C0023671 (UMLS CUI [1])

Able to swallow Oral medication

Item

patients must be able to take oral medication.

boolean

C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])

Normal serum calcium level

Item

serum calcium within normal ranges

boolean

C0580486 (UMLS CUI [1])

Operative Surgical Procedures | Therapeutic radiology procedure

Item

≥ 4 weeks since prior surgery or radiation therapy

boolean

C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Item

for all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception

boolean

C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])

Age

Item

18 years of age or older

boolean

C0001779 (UMLS CUI [1])

Informed Consent

Item

written (signed) informed consent to participate in the study

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Cancer treatment Systemic

Item

prior systemic antitumor therapy

boolean

C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])

Item

any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (uln) or ast and/or alt ≥ 2 x uln (or ≥ 5 x uln if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x uln.

boolean

C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0679861 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0021390 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0859062 (UMLS CUI [9])
C0151904 (UMLS CUI [10])
C0151905 (UMLS CUI [11])
C0439849 (UMLS CUI [12,1])
C0494165 (UMLS CUI [12,2])
C0022658 (UMLS CUI [13])
C0035078 (UMLS CUI [14])
C0700225 (UMLS CUI [15])

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Item

any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])

Breast Feeding | Pregnancy

Item

nursing mothers or pregnant woman.

boolean

C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])

Hypersensitivity Tarceva | Hypersensitivity Pharmaceutical Formulation Tarceva Similar

Item

hypersensitivity to tarceva or co-formulants.

boolean

C0020517 (UMLS CUI [1,1])
C1135136 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705957 (UMLS CUI [2,2])
C1135136 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])

Metastatic malignant neoplasm to brain | Compression of spinal cord | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent

Item

patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.

boolean

C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])

Metastatic malignant neoplasm to brain | Compression of spinal cord | Patient's condition unstable | Steroid therapy Resistant

Item

patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.

boolean

C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0438114 (UMLS CUI [3])
C0149783 (UMLS CUI [4,1])
C0332325 (UMLS CUI [4,2])

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Eligibility Non Small Cell Lung Cancer NCT00452075