ID

21520

Beschrijving

Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00440414

Link

https://clinicaltrials.gov/show/NCT00440414

Trefwoorden

  1. 25-04-17 25-04-17 -
Geüploaded op

25 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Non Small Cell Lung Cancer NCT00440414

Eligibility Non Small Cell Lung Cancer NCT00440414

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Non-small-cell lung cancer

Datatype

boolean

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

Tumor stage

Datatype

boolean

Alias
UMLS CUI [1]
C1300072
failure to prior chemotherapy
Beschrijving

Prior chemotherapy

Datatype

boolean

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

Measurable disease

Datatype

boolean

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

CNS Metastases

Datatype

boolean

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

Life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
tissue sample desired for genomic study
Beschrijving

Tissue sample for genomic study

Datatype

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0887950
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

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

Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
for patients > 65 years old: "non-frail" according to comprehensive geriatric assessment
Beschrijving

Geriatric Assessment

Datatype

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)
Beschrijving

Absolute Neutrophil Count, Platelets, Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0518015
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)
Beschrijving

Liver and Renal Function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
presence of a reliable care giver for patients > 65 years old
Beschrijving

Caregiver

Datatype

boolean

Alias
UMLS CUI [1]
C0085537
informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
other concurrent uncontrolled illness
Beschrijving

Comorbidity

Datatype

boolean

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

Malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Non Small Cell Lung Cancer NCT00440414

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-small-cell lung cancer
Item
histologically- or cytologically- confirmed non-small-cell lung cancer adenocarcinoma
boolean
C0007131 (UMLS CUI [1])
Tumor stage
Item
stage iiib/iv
boolean
C1300072 (UMLS CUI [1])
Prior chemotherapy
Item
failure to 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])
Tissue sample for genomic study
Item
tissue sample desired for genomic study
boolean
C1292533 (UMLS CUI [1,1])
C0887950 (UMLS CUI [1,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Performance Status
Item
performance status (who) < 3
boolean
C1518965 (UMLS CUI [1])
Geriatric Assessment
Item
for patients > 65 years old: "non-frail" according to comprehensive geriatric assessment
boolean
C0017463 (UMLS CUI [1])
Absolute 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])
C0518015 (UMLS CUI [3])
Liver and Renal Function
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
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Caregiver
Item
presence of a reliable care giver for patients > 65 years old
boolean
C0085537 (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])
Malignancy
Item
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
boolean
C0006826 (UMLS CUI [1])

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