ID

18477

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.11.16 07.11.16 -
Hochgeladen am

7. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00173888

Englisch

Eligibility Non-small Cell Lung Cancer NCT00173888

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of stage iiib/iv nsclc, no prior chemotherapy
Beschreibung

Non-Small Cell Lung Carcinoma | TNM clinical staging | Prior Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
UMLS CUI [3]
C1514457
age > 18 years and < 75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
who ps: 0,1
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
unidimensional or bi-dimensional measurable disease
Beschreibung

Measurable Disease Linear | Measurable Disease 2-Dimensional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0019046
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
UMLS CUI [8]
C0153690
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0332197
creatinine < 1 unl, and creatinine clearance should be > 60 ml/min.
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
life expectancy > 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant, or lactating patients
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known clinical brain or leptomeningeal involvement
Beschreibung

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
pre-existing motor or sensory neurotoxicity of a severity > grade 1 by ncic-ctg criteria
Beschreibung

Motor neuropathy Pre-existing | Sensory neuropathy Pre-existing | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235025
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0151313
UMLS CUI [2,2]
C2347662
UMLS CUI [3]
C1516728
chf, angina or arrhythmias
Beschreibung

Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0003811
history of significant neurological or psychiatric disorders
Beschreibung

nervous system disorder Significant | Mental disorders Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
active uncontrolled infection
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
contraindication for the use of corticosteroids
Beschreibung

Medical contraindication Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
concurrent treatment with other experimental drugs within 30 days prior to study entry
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
concurrent treatment with any other anti-cancer therapy
Beschreibung

cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT00173888

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Life Expectancy
Item
life expectancy > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant, or lactating patients
boolean
C0032961 (UMLS CUI [1])
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])
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])
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])
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])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
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])
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])
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