ID

17940

Description

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene; ODM derived from: https://clinicaltrials.gov/show/NCT00588445

Link

https://clinicaltrials.gov/show/NCT00588445

Keywords

Versions (1)
  1. 10/11/16 10/11/16 -
Uploaded on

October 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00588445

English

Eligibility Lung Cancer NCT00588445

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic confirmation of malignancy at memorial sloan-kettering
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patients must have previously untreated stage i or ii nsclc (t11-2n0m0, t1-2n1m0, t3n0m0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure bac, bac with focal invasion or adenocarcinoma with bac features)
Description

Non-Small Cell Lung Carcinoma untreated | TNM clinical staging | Never smoked tobacco | smoking cigarettes: ____ pack-years history | LUNG CANCER BRONCHIOLOALVEOLAR | LUNG CANCER BRONCHIOLOALVEOLAR Tumor Cell Invasion Focal | Lung Adenocarcinoma with bronchioloalveolar features

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0425293
UMLS CUI [4]
C2230126
UMLS CUI [5]
C0746077
UMLS CUI [6,1]
C0746077
UMLS CUI [6,2]
C1269955
UMLS CUI [6,3]
C0205234
UMLS CUI [7]
C1879591
patients must have been determined to be operable and resectable by the treating thoracic surgeon.
Description

Patients Determination Operable | Patients Determination Resectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1148554
UMLS CUI [1,3]
C0205188
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1148554
UMLS CUI [2,3]
C1514888
age >18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
measurable indicator lesions
Description

Measurable Disease Indicator

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0021212
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women or women of childbearing potential not using effective contraception. men participating in the trial must also use effective contraception when sexually active.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Sex Behavior Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0036864
UMLS CUI [4,3]
C0700589
patients may not be receiving any other investigational agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
Description

Interstitial Lung Diseases Evidence of | Changes roentgenographic Stable chronic Asymptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0034571
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0205191
UMLS CUI [2,5]
C0231221
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Similar models

Eligibility Lung Cancer NCT00588445

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Malignant Neoplasms
Item
pathologic confirmation of malignancy at memorial sloan-kettering
boolean
C0006826 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma untreated | TNM clinical staging | Never smoked tobacco | smoking cigarettes: ____ pack-years history | LUNG CANCER BRONCHIOLOALVEOLAR | LUNG CANCER BRONCHIOLOALVEOLAR Tumor Cell Invasion Focal | Lung Adenocarcinoma with bronchioloalveolar features
Item
patients must have previously untreated stage i or ii nsclc (t11-2n0m0, t1-2n1m0, t3n0m0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure bac, bac with focal invasion or adenocarcinoma with bac features)
boolean
C0007131 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0425293 (UMLS CUI [3])
C2230126 (UMLS CUI [4])
C0746077 (UMLS CUI [5])
C0746077 (UMLS CUI [6,1])
C1269955 (UMLS CUI [6,2])
C0205234 (UMLS CUI [6,3])
C1879591 (UMLS CUI [7])
Patients Determination Operable | Patients Determination Resectable
Item
patients must have been determined to be operable and resectable by the treating thoracic surgeon.
boolean
C0030705 (UMLS CUI [1,1])
C1148554 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1148554 (UMLS CUI [2,2])
C1514888 (UMLS CUI [2,3])
Age
Item
age >18 years.
boolean
C0001779 (UMLS CUI [1])
Measurable Disease Indicator
Item
measurable indicator lesions
boolean
C1513041 (UMLS CUI [1,1])
C0021212 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Sex Behavior Contraceptive methods
Item
pregnant or lactating women or women of childbearing potential not using effective contraception. men participating in the trial must also use effective contraception when sexually active.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0036864 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Investigational New Drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Interstitial Lung Diseases Evidence of | Changes roentgenographic Stable chronic Asymptomatic
Item
any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
boolean
C0206062 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
C0231221 (UMLS CUI [2,5])
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