Informações:
Falhas:
ID
18477
Descrição
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00173888
Link
https://clinicaltrials.gov/show/NCT00173888
Palavras-chave
Versões (1)
- 07/11/2016 07/11/2016 -
Transferido a
7 de novembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00173888
Eligibility Non-small Cell Lung Cancer NCT00173888
- StudyEvent: Eligibility
Similar models
Eligibility Non-small Cell Lung Cancer NCT00173888
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Non-Small Cell Lung Carcinoma | TNM clinical staging | Prior Chemotherapy
Item
histologic or cytologic diagnosis of stage iiib/iv nsclc, no prior chemotherapy
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C1514457 (UMLS CUI [3])
C3258246 (UMLS CUI [2])
C1514457 (UMLS CUI [3])
Age
Item
age > 18 years and < 75 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who ps: 0,1
boolean
C1298650 (UMLS CUI [1])
Measurable Disease Linear | Measurable Disease 2-Dimensional
Item
unidimensional or bi-dimensional measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C0205132 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Hemoglobin | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone | Liver diseases Absent
Item
neutrophils > 1.5 109/l, platelets > 100 109/l, hemoglobin > 10g/dl, total bilirubin < 1.5 unl, ast (sgot) and alt (sgpt) < 2.5 unl, alkaline phosphatases < 5 unl; except in presence of only bone metastasis and in the absence of any liver disorders
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C0153690 (UMLS CUI [8])
C0023895 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C0153690 (UMLS CUI [8])
C0023895 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine < 1 unl, and creatinine clearance should be > 60 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0373595 (UMLS CUI [2])
Life Expectancy
Item
life expectancy > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant, or lactating patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
known clinical brain or leptomeningeal involvement
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
C1704231 (UMLS CUI [2])
Motor neuropathy Pre-existing | Sensory neuropathy Pre-existing | CTCAE Grades
Item
pre-existing motor or sensory neurotoxicity of a severity > grade 1 by ncic-ctg criteria
boolean
C0235025 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0151313 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1516728 (UMLS CUI [3])
C2347662 (UMLS CUI [1,2])
C0151313 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1516728 (UMLS CUI [3])
Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia
Item
chf, angina or arrhythmias
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0002962 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
nervous system disorder Significant | Mental disorders Significant
Item
history of significant neurological or psychiatric disorders
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])
Medical contraindication Adrenal Cortex Hormones
Item
contraindication for the use of corticosteroids
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,2])
Investigational New Drugs
Item
concurrent treatment with other experimental drugs within 30 days prior to study entry
boolean
C0013230 (UMLS CUI [1])
cancer treatment
Item
concurrent treatment with any other anti-cancer therapy
boolean
C0920425 (UMLS CUI [1])