Eligibility Lung Cancer NCT00989690

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging
Item
advanced nsclc (stage iiib or iv)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
TNK1 Inhibitor | First line treatment Non-Small Cell Lung Carcinoma Advanced
Item
underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced nsclc
boolean
C0387990 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
Absence Metastatic malignant neoplasm to brain Uncontrolled
Item
no clinical evidence of uncontrolled brain metastases
boolean
C0332197 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Caucasians
Item
caucasian
boolean
C0043157 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute granulocyte count ≥ 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement | Secondary malignant neoplasm of liver
Item
bilirubin ≤ 1.5 times upper limit of normal (uln) (≤ 2.5 times uln in patients with known liver metastases)
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alt or ast ≤ 3 times uln (≤ 5 times uln in patients with known liver metastases)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Creatinine clearance measurement
Item
creatinine clearance ≥ 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Protocol Compliance
Item
able to comply with planned study procedures
boolean
C0525058 (UMLS CUI [1])
Exclusion Criteria | Multiple diseases Severe compromise Safety | Heart failure | Kidney Failure | Peripheral Neuropathy
Item
no multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
boolean
C0680251 (UMLS CUI [1])
C1404410 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C0036043 (UMLS CUI [2,4])
C0018801 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C0031117 (UMLS CUI [5])
Exclusion Criteria | Cancer Other | Exception Basal cell carcinoma | Preneoplastic Condition Requirement Chemotherapy
Item
no other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment
boolean
C0680251 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0282313 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.19
Item
see disease characteristics
boolean
Operative Surgical Procedures Previous | Prior radiation therapy
Item
at least 3 weeks since prior surgery or radiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])
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