ID

18400

Description

Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00441922

Link

https://clinicaltrials.gov/show/NCT00441922

Keywords

Versions (1)
  1. 11/3/16 11/3/16 -
Uploaded on

November 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00441922

English

Eligibility Non Small Cell Lung Cancer NCT00441922

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically- or cytologically- confirmed non-small-cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
stage iiib/iv
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
no prior chemotherapy
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
existence of two-dimensional measurable disease. the measurable disease should not have been irradiated
Description

Measurable Disease 2-Dimensional | Therapeutic radiology procedure Measurable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1513041
life expectancy of more than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
age ≥ 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status (who) ≤ 3
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
Description

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0019046
adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
psychiatric illness or social situation that would preclude study compliance.
Description

Mental disorder Excludes Protocol Compliance | social situation Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
other concurrent uncontrolled illness
Description

Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Description

invasive cancer | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
no absence or irradiated and stable central nervous system metastatic disease.
Description

CNS metastases Presence | Therapeutic radiology procedure CNS metastases | CNS metastases Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0150312
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0686377
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C0205360
no presence of a reliable care giver
Description

Caregiver Absence

Data type

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C0332197
other concurrent investigational agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00441922

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically- or cytologically- confirmed non-small-cell lung cancer
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging
Item
stage iiib/iv
boolean
C3258246 (UMLS CUI [1])
Prior Chemotherapy
Item
no prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Measurable Disease 2-Dimensional | Therapeutic radiology procedure Measurable Disease
Item
existence of two-dimensional measurable disease. the measurable disease should not have been irradiated
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
age ≥ 65 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
performance status (who) ≤ 3
boolean
C1298650 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorder Excludes Protocol Compliance | social situation Excludes Protocol Compliance
Item
psychiatric illness or social situation that would preclude study compliance.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Comorbidity Uncontrolled
Item
other concurrent uncontrolled illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
invasive cancer | Skin carcinoma
Item
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
CNS metastases Presence | Therapeutic radiology procedure CNS metastases | CNS metastases Stable
Item
no absence or irradiated and stable central nervous system metastatic disease.
boolean
C0686377 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Caregiver Absence
Item
no presence of a reliable care giver
boolean
C0085537 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Investigational New Drugs
Item
other concurrent investigational agents
boolean
C0013230 (UMLS CUI [1])
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