ID

21441

Descripción

Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193414

Link

https://clinicaltrials.gov/show/NCT00193414

Palabras clave

Versiones (1)
  1. 21/4/17 21/4/17 -
Subido en

21 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00193414

Inglés

Eligibility Lung Cancer NCT00193414

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Criteria Fulfill

Tipo de datos

boolean

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

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
newly diagnosed or recurrent unresectable stage iii or stage iv disease
Descripción

Newly Diagnosed Disease TNM clinical staging | Recurrent disease unresectable TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1334965
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1519810
UMLS CUI [2,3]
C3258246
no mixed tumors with small cell anaplastic elements
Descripción

Mixed Neoplasm Anaplastic Cell Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1368354
UMLS CUI [1,2]
C1515964
UMLS CUI [1,3]
C0332197
measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
must not have received any prior antineoplastic chemotherapy for lung cancer
Descripción

Carcinoma of lung Chemotherapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0684249
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0332197
age > 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
able to perform activities of daily living with little or no assistance
Descripción

Activities of Daily Living Perform Able

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001288
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0085732
adequate bone marrow, liver and kidney
Descripción

Bone Marrow function | Liver function | Renal function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
understand the nature of this study and give written informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
female patients who are pregnant or are lactating
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of serious cardiovascular disease within the previous six months
Descripción

Cardiovascular Disease Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205404
serious active infection at the time of treatment
Descripción

Communicable Disease Serious

Tipo de datos

boolean

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

Comorbidity Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
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.
Descripción

Clinical Trial Eligibility Criteria Additional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Lung Cancer NCT00193414

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell bronchogenic carcinoma
boolean
C0007131 (UMLS CUI [1])
Newly Diagnosed Disease TNM clinical staging | Recurrent disease unresectable TNM clinical staging
Item
newly diagnosed or recurrent unresectable stage iii or stage iv disease
boolean
C1334965 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
Mixed Neoplasm Anaplastic Cell Absent
Item
no mixed tumors with small cell anaplastic elements
boolean
C1368354 (UMLS CUI [1,1])
C1515964 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Carcinoma of lung Chemotherapy Absent
Item
must not have received any prior antineoplastic chemotherapy for lung cancer
boolean
C0684249 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Activities of Daily Living Perform Able
Item
able to perform activities of daily living with little or no assistance
boolean
C0001288 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and kidney
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Informed Consent
Item
understand the nature of this study and give written informed consent.
boolean
C0021430 (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 patients who are pregnant or are lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Disease Serious
Item
history of serious cardiovascular disease within the previous six months
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Communicable Disease Serious
Item
serious active infection at the time of treatment
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Comorbidity Serious
Item
other serious underlying medical condition
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Additional
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
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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