ID

17932

Beschrijving

Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193362

Link

https://clinicaltrials.gov/show/NCT00193362

Trefwoorden

Versies (1)
  1. 10-10-16 10-10-16 -
Geüploaded op

10 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00193362

Engels

Eligibility Lung Cancer NCT00193362

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in this study, you must meet the following criteria:
Beschrijving

criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
non-small cell bronchogenic carcinoma
Beschrijving

Bronchogenic Carcinoma Non-small cell

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007121
UMLS CUI [1,2]
C0445128
newly diagnosed unresectable stage iiib or stage iv disease
Beschrijving

Carcinoma unresectable | TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C3258246
patients with stage iiib disease should be ineligible for combined therapy
Beschrijving

TNM clinical staging | Patients Ineligible Combined Modality Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1512714
UMLS CUI [2,3]
C0009429
patients must have measurable lesion definable by x-ray or ct scan.
Beschrijving

Measurable Disease | roentgenography | X-Ray Computed Tomography

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0034571
UMLS CUI [3]
C0040405
no prior antineoplastic chemotherapy for lung cancer prior to study entry
Beschrijving

Chemotherapy Carcinoma of lung

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0684249
age > 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
able to perform activities of daily living with minimal assistance
Beschrijving

Aids to daily living Minimal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1283236
UMLS CUI [1,2]
C1524031
adequate bone marrow, liver and kidney function
Beschrijving

Bone Marrow function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
written informed consent must be obtained prior to study entry
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients must be available for treatment and followup.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot participate in this study if any of the following apply to you:
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
female patient pregnant or lactating
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of heart disease
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
serious active infection at the time of treatment
Beschrijving

Communicable Disease Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
other serious underlying medical condition
Beschrijving

Other medical condition Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
brain metastasis
Beschrijving

Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
patients without measurable disease
Beschrijving

Measurable Disease Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0332268
uncontrolled diabetes mellitus defined as random blood sugar > 250mg/dl
Beschrijving

Diabetic - poor control | Random blood glucose level result

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C1261429
dementia or significantly altered mental status
Beschrijving

Dementia | Mental state altered Significant

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0278060
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0750502
significant peripheral neuropathy by history or physical examination.
Beschrijving

Peripheral Neuropathy Significant | Physical Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0031809
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Beschrijving

criteria Study Protocol | Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C2348568
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Similar models

Eligibility Lung Cancer NCT00193362

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
criteria Fulfill
Item
to be included in this study, you must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Bronchogenic Carcinoma Non-small cell
Item
non-small cell bronchogenic carcinoma
boolean
C0007121 (UMLS CUI [1,1])
C0445128 (UMLS CUI [1,2])
Carcinoma unresectable | TNM clinical staging
Item
newly diagnosed unresectable stage iiib or stage iv disease
boolean
C0007097 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
TNM clinical staging | Patients Ineligible Combined Modality Therapy
Item
patients with stage iiib disease should be ineligible for combined therapy
boolean
C3258246 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C0009429 (UMLS CUI [2,3])
Measurable Disease | roentgenography | X-Ray Computed Tomography
Item
patients must have measurable lesion definable by x-ray or ct scan.
boolean
C1513041 (UMLS CUI [1])
C0034571 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
Chemotherapy Carcinoma of lung
Item
no prior antineoplastic chemotherapy for lung cancer prior to study entry
boolean
C0392920 (UMLS CUI [1,1])
C0684249 (UMLS CUI [1,2])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Aids to daily living Minimal
Item
able to perform activities of daily living with minimal assistance
boolean
C1283236 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and kidney function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Informed Consent
Item
written informed consent must be obtained prior to study entry
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
patients must be available for treatment and followup.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
you cannot participate in this study if any of the following apply to you:
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female patient pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease
Item
history of heart disease
boolean
C0018799 (UMLS CUI [1])
Communicable Disease Serious
Item
serious active infection at the time of treatment
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Other medical condition Serious
Item
other serious underlying medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
brain metastasis
boolean
C0220650 (UMLS CUI [1])
Measurable Disease Lacking
Item
patients without measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Diabetic - poor control | Random blood glucose level result
Item
uncontrolled diabetes mellitus defined as random blood sugar > 250mg/dl
boolean
C0421258 (UMLS CUI [1])
C1261429 (UMLS CUI [2])
Dementia | Mental state altered Significant
Item
dementia or significantly altered mental status
boolean
C0497327 (UMLS CUI [1])
C0278060 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
Peripheral Neuropathy Significant | Physical Examination
Item
significant peripheral neuropathy by history or physical examination.
boolean
C0031117 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
criteria Study Protocol | Study Subject Participation Status
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean
C0243161 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
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