ID

30303

Beskrivning

Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01130753

Länk

https://clinicaltrials.gov/show/NCT01130753

Nyckelord

Versioner (1)
  1. 2018-05-27 2018-05-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lung Neoplasms NCT01130753

Engelsk

Eligibility Lung Neoplasms NCT01130753

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed n2 positive and stage iiia non-small cell lung cancer
Beskrivning

Non-Small Cell Lung Carcinoma N2 Positive TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0441960
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C3258246
has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women
Beskrivning

Adenocarcinoma | Non-smoker | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001418
UMLS CUI [2]
C0337672
UMLS CUI [3]
C0079399
age ≥ 18 years and ecog performance 0~1
Beskrivning

Age | ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
has measurable lesion by recist 1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
no previous chemotherapy or radiation therapy
Beskrivning

Prior Chemotherapy Absent | Prior radiation therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
adequate organ function by following; anc ≥1,500/ul, hemoglobin ≥9.0g/dl, platelet
Beskrivning

Organ function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
≥100,000/ul, pao2 ≥ 60 mmhg, serum cr < 1 x unl or creatinine clearance > 60 ml/min, serum bilirubin < 1 x unl, ast (sgot) and alt (sgpt) < 2.5 x unl, alkaline phosphatase < 5 x unl
Beskrivning

PaO2 | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202155
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
written informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pulmonary carcinoid tumor
Beskrivning

Carcinoid tumor of lung

Datatyp

boolean

Alias
UMLS CUI [1]
C0280089
previous chemotherapy or radiation therapy
Beskrivning

Prior Chemotherapy | Prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
known allergic history of erlotinib
Beskrivning

Hypersensitivity Erlotinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
interstitial lung disease or fibrosis on chest radiogram
Beskrivning

Interstitial Lung Disease Chest radiography | Fibrosis Chest radiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C0016059
UMLS CUI [2,2]
C0039985
active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
Beskrivning

Communicable Disease | Systemic disease Uncontrolled | Cardiopulmonary insufficiency | Cardiac Arrhythmia Fatal | Hepatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0920033
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C1302234
UMLS CUI [5]
C0019158
pregnant or nursing women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Lung Neoplasms NCT01130753

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma N2 Positive TNM clinical staging
Item
pathologically confirmed n2 positive and stage iiia non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C0441960 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Adenocarcinoma | Non-smoker | Gender
Item
has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women
boolean
C0001418 (UMLS CUI [1])
C0337672 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Age | ECOG performance status
Item
age ≥ 18 years and ecog performance 0~1
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Measurable Disease
Item
has measurable lesion by recist 1.1
boolean
C1513041 (UMLS CUI [1])
Prior Chemotherapy Absent | Prior radiation therapy Absent
Item
no previous chemotherapy or radiation therapy
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Organ function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
adequate organ function by following; anc ≥1,500/ul, hemoglobin ≥9.0g/dl, platelet
boolean
C0678852 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
PaO2 | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
≥100,000/ul, pao2 ≥ 60 mmhg, serum cr < 1 x unl or creatinine clearance > 60 ml/min, serum bilirubin < 1 x unl, ast (sgot) and alt (sgpt) < 2.5 x unl, alkaline phosphatase < 5 x unl
boolean
C0202155 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
Informed Consent
Item
written informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Carcinoid tumor of lung
Item
pulmonary carcinoid tumor
boolean
C0280089 (UMLS CUI [1])
Prior Chemotherapy | Prior radiation therapy
Item
previous chemotherapy or radiation therapy
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Hypersensitivity Erlotinib
Item
known allergic history of erlotinib
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
Interstitial Lung Disease Chest radiography | Fibrosis Chest radiography
Item
interstitial lung disease or fibrosis on chest radiogram
boolean
C0206062 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0016059 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
Communicable Disease | Systemic disease Uncontrolled | Cardiopulmonary insufficiency | Cardiac Arrhythmia Fatal | Hepatitis
Item
active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
boolean
C0009450 (UMLS CUI [1])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0920033 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C1302234 (UMLS CUI [4,2])
C0019158 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tillbaka till toppen 

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