ID

22080

Beskrivning

Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV; ODM derived from: https://clinicaltrials.gov/show/NCT00615758

Länk

https://clinicaltrials.gov/show/NCT00615758

Nyckelord

Versioner (1)
  1. 2017-05-18 2017-05-18 -
Uppladdad den

18 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00615758

Engelsk

Eligibility Non Small Cell Lung Cancer NCT00615758

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed, unresectable locally advanced (stage iiib with pleural effusion) and/or metastatic (stage iv) nsclc
Beskrivning

Non-Small Cell Lung Carcinoma Advanced Local Unresectable TNM clinical staging | Pleural effusion | Non-small cell lung cancer metastatic TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C1519810
UMLS CUI [1,5]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3,1]
C0278987
UMLS CUI [3,2]
C3258246
no previous therapy for advanced/metastatic nsclc is allowed
Beskrivning

Non-Small Cell Lung Carcinoma Advanced Therapeutic procedure Absent | Non-small cell lung cancer metastatic Therapeutic procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0332197
age >18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
bidimensionally measurable disease
Beskrivning

Measurable Disease 2-Dimensional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
non-smokers (or ex-smokers with less than 5 pack-years smoking history)
Beskrivning

Non-smoker | Former smoker Smoking cigarettes: ____ pack-years history

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C2230126
adenocarcinoma histology
Beskrivning

Adenocarcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0001418
performance status (who) 0-3
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
adequate liver (serum bilirubin <1.5 times the upper normal limit (unl); ast and alt <2.5 times the unl in the absence of demonstrable liver metastases, or <5 times the unl in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the unl); and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
Beskrivning

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C0494165
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0494165
UMLS CUI [6,2]
C0150312
UMLS CUI [7]
C0232804
UMLS CUI [8]
C0201976
UMLS CUI [9,1]
C0005953
UMLS CUI [9,2]
C0031843
UMLS CUI [10]
C0200633
UMLS CUI [11]
C0032181
previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
Beskrivning

Radiotherapy, Adjuvant | Therapeutic radiology procedure Neoplasm Metastasis | Measurable lesion outside Radiation Field

Datatyp

boolean

Alias
UMLS CUI [1]
C0242939
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0027627
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0205101
UMLS CUI [3,3]
C1882536
patient able to take oral medication
Beskrivning

Able to swallow oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
tissue sample for tumour mutational analysis is required
Beskrivning

Tissue sample available | Neoplasm mutation analysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0796357
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
Beskrivning

Chronic disease of skin Serious Study Subject Participation Status Excluded | Psoriasis | Eczema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1290009
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C2828389
UMLS CUI [2]
C0033860
UMLS CUI [3]
C0013595
active infection
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Beskrivning

Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
malnutrition (loss of ≥ 20% of the original body weight)
Beskrivning

Malnutrition | Weight decreased Percentage | Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0162429
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C0005910
performance status: 4
Beskrivning

performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
psychiatric illness or social situation that would preclude study compliance
Beskrivning

Mental disorder Protocol Compliance Excluded | Social situation Protocol Compliance Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C2828389
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00615758

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Local Unresectable TNM clinical staging | Pleural effusion | Non-small cell lung cancer metastatic TNM clinical staging
Item
histologically or cytologically confirmed, unresectable locally advanced (stage iiib with pleural effusion) and/or metastatic (stage iv) nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C3258246 (UMLS CUI [1,5])
C0032227 (UMLS CUI [2])
C0278987 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Non-Small Cell Lung Carcinoma Advanced Therapeutic procedure Absent | Non-small cell lung cancer metastatic Therapeutic procedure Absent
Item
no previous therapy for advanced/metastatic nsclc is allowed
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease 2-Dimensional
Item
bidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
Non-smoker | Former smoker Smoking cigarettes: ____ pack-years history
Item
non-smokers (or ex-smokers with less than 5 pack-years smoking history)
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
Adenocarcinoma
Item
adenocarcinoma histology
boolean
C0001418 (UMLS CUI [1])
WHO performance status scale
Item
performance status (who) 0-3
boolean
C1298650 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Neutrophil count | Platelet Count measurement
Item
adequate liver (serum bilirubin <1.5 times the upper normal limit (unl); ast and alt <2.5 times the unl in the absence of demonstrable liver metastases, or <5 times the unl in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the unl); and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0494165 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0494165 (UMLS CUI [6,1])
C0150312 (UMLS CUI [6,2])
C0232804 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C0031843 (UMLS CUI [9,2])
C0200633 (UMLS CUI [10])
C0032181 (UMLS CUI [11])
Radiotherapy, Adjuvant | Therapeutic radiology procedure Neoplasm Metastasis | Measurable lesion outside Radiation Field
Item
previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
boolean
C0242939 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0205101 (UMLS CUI [3,2])
C1882536 (UMLS CUI [3,3])
Able to swallow oral medication
Item
patient able to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Tissue sample available | Neoplasm mutation analysis
Item
tissue sample for tumour mutational analysis is required
boolean
C1292533 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0796357 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Chronic disease of skin Serious Study Subject Participation Status Excluded | Psoriasis | Eczema
Item
serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
boolean
C1290009 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
C0033860 (UMLS CUI [2])
C0013595 (UMLS CUI [3])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Malnutrition | Weight decreased Percentage | Body Weight
Item
malnutrition (loss of ≥ 20% of the original body weight)
boolean
C0162429 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0005910 (UMLS CUI [3])
performance status
Item
performance status: 4
boolean
C1518965 (UMLS CUI [1])
Mental disorder Protocol Compliance Excluded | Social situation Protocol Compliance Excluded
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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