ID

21535

Description

Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00442026

Link

https://clinicaltrials.gov/show/NCT00442026

Keywords

  1. 4/26/17 4/26/17 -
Uploaded on

April 26, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Non-small-cell Lung Cancer NCT00442026

Eligibility Non-small-cell Lung Cancer NCT00442026

Inclusion Criteria
Description

Inclusion Criteria

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

Non-small-cell lung cancer

Data type

boolean

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

Tumor Stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
no prior chemotherapy
Description

Prior chemotherapy

Data type

boolean

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

Measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
absence or irradiated and stable central nervous system metastatic disease
Description

CNS Metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
life expectancy of more than 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
age ≥ 70 years.
Description

Age

Data type

boolean

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

Performance Stataus

Data type

boolean

Alias
UMLS CUI [1]
C1518965
patients "non-frail" according to comprehensive geriatric assessment
Description

Geriatric Assessment

Data type

boolean

Alias
UMLS CUI [1]
C0017463
adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3).
Description

Absoulute neutrophil count, platelets, hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl).
Description

Bilirubin, SGOT, SGPT, Creatinine

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201976
adequate cardiac function (lvef > 50%).
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
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

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
other concurrent uncontrolled illness.
Description

Comorbidity

Data type

boolean

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

Prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C2735088
no presence of a reliable care giver
Description

Caregiver

Data type

boolean

Alias
UMLS CUI [1]
C0085537
other concurrent investigational agents.
Description

Experimental drugs

Data type

boolean

Alias
UMLS CUI [1]
C0304229

Similar models

Eligibility Non-small-cell Lung Cancer NCT00442026

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-small-cell lung cancer
Item
histologically- or cytologically- confirmed non-small-cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Tumor Stage
Item
stage iiib/iv
boolean
C1300072 (UMLS CUI [1])
Prior chemotherapy
Item
no prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Measurable disease
Item
presence of two-dimensional measurable disease. the measurable disease should not have been irradiated.
boolean
C1513041 (UMLS CUI [1])
CNS Metastases
Item
absence or irradiated and stable central nervous system metastatic disease
boolean
C0686377 (UMLS CUI [1])
Life expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
age ≥ 70 years.
boolean
C0001779 (UMLS CUI [1])
Performance Stataus
Item
performance status (who) < 3
boolean
C1518965 (UMLS CUI [1])
Geriatric Assessment
Item
patients "non-frail" according to comprehensive geriatric assessment
boolean
C0017463 (UMLS CUI [1])
Absoulute neutrophil count, platelets, hemoglobin
Item
adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3).
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Bilirubin, SGOT, SGPT, Creatinine
Item
adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl).
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Left ventricular ejection fraction
Item
adequate cardiac function (lvef > 50%).
boolean
C0428772 (UMLS CUI [1])
Informed consent
Item
informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Compliance
Item
psychiatric illness or social situation that would preclude study compliance.
boolean
C1321605 (UMLS CUI [1])
Comorbidity
Item
other concurrent uncontrolled illness.
boolean
C0009488 (UMLS CUI [1])
Prior malignancy
Item
other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
boolean
C2735088 (UMLS CUI [1])
Caregiver
Item
no presence of a reliable care giver
boolean
C0085537 (UMLS CUI [1])
Experimental drugs
Item
other concurrent investigational agents.
boolean
C0304229 (UMLS CUI [1])

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