ID

31208

Beschreibung

Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00749567

Link

https://clinicaltrials.gov/show/NCT00749567

Stichworte

Versionen (1)
  1. 29.07.18 29.07.18 -
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See clinicaltrials.gov

Hochgeladen am

29. Juli 2018

DOI

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Eligibility Non-small-cell Lung Cancer NCT00749567

Englisch

Eligibility Non-small-cell Lung Cancer NCT00749567

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C1519810
UMLS CUI [1,5]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3,1]
C0278987
UMLS CUI [3,2]
C1519810
UMLS CUI [3,3]
C3258246
progression to first-line therapy for advanced/metastatic nsclc
Beschreibung

Disease Progression | First line treatment Non-Small Cell Lung Carcinoma Advanced | First line treatment Non-small cell lung cancer metastatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0205179
UMLS CUI [3,1]
C1708063
UMLS CUI [3,2]
C0278987
bi-dimensionally measurable disease (not included in radiation field)
Beschreibung

Measurable Disease 2-Dimensional outside Radiation Field

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C0205101
UMLS CUI [1,4]
C1882536
ecog performance status of 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of more than 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate liver (serum bilirubin <1.5 times the upper normal limit, ast and alt <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine <1.5 times the upper normal limit),and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
Beschreibung

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

Datentyp

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
signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
Beschreibung

Central Nervous System Involvement | Exception Therapeutic radiology procedure | Exception Patient Stable status

Datentyp

boolean

Alias
UMLS CUI [1]
C4050309
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0030705
UMLS CUI [3,3]
C0205360
presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
Beschreibung

Mass Location Central | Tumor Mass Relation Large vessels | Mass Cavitation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577559
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205099
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0225990
UMLS CUI [3,1]
C0577559
UMLS CUI [3,2]
C1510420
surgery or radiation therapy within the last 14 days from study entry
Beschreibung

Operative Surgical Procedures | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
active infection
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
history of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
Beschreibung

Hemoptysis Life Threatening | Hematemesis | Thrombosis | Anticoagulation Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0018926
UMLS CUI [3]
C0040053
UMLS CUI [4]
C0003281
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension
Beschreibung

Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia | Cerebrovascular accident | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
UMLS CUI [6]
C0038454
UMLS CUI [7]
C1868885
patients on other experimental treatment protocols
Beschreibung

Study Subject Participation Status | Treatment Protocols Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0040808
UMLS CUI [2,2]
C1517586
history of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix)
Beschreibung

Primary tumor second | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205436
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
psychiatric illness or social situation that would preclude study compliance
Beschreibung

Mental disorders Protocol Compliance Excluded | Social situation Protocol Compliance Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0332196
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Non-small-cell Lung Cancer NCT00749567

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally unresectable TNM clinical staging | Pleural effusion | Non-small cell lung cancer metastatic unresectable 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])
C1517927 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C3258246 (UMLS CUI [1,5])
C0032227 (UMLS CUI [2])
C0278987 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
Disease Progression | First line treatment Non-Small Cell Lung Carcinoma Advanced | First line treatment Non-small cell lung cancer metastatic
Item
progression to first-line therapy for advanced/metastatic nsclc
boolean
C0242656 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C1708063 (UMLS CUI [3,1])
C0278987 (UMLS CUI [3,2])
Measurable Disease 2-Dimensional outside Radiation Field
Item
bi-dimensionally measurable disease (not included in radiation field)
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0205101 (UMLS CUI [1,3])
C1882536 (UMLS CUI [1,4])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of more than 6 months
boolean
C0023671 (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, ast and alt <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine <1.5 times the upper normal limit),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])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Central Nervous System Involvement | Exception Therapeutic radiology procedure | Exception Patient Stable status
Item
central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
boolean
C4050309 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0030705 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Mass Location Central | Tumor Mass Relation Large vessels | Mass Cavitation
Item
presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
boolean
C0577559 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205099 (UMLS CUI [1,3])
C3273930 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0225990 (UMLS CUI [2,3])
C0577559 (UMLS CUI [3,1])
C1510420 (UMLS CUI [3,2])
Operative Surgical Procedures | Therapeutic radiology procedure
Item
surgery or radiation therapy within the last 14 days from study entry
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Hemoptysis Life Threatening | Hematemesis | Thrombosis | Anticoagulation Therapy
Item
history of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
boolean
C0019079 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0018926 (UMLS CUI [2])
C0040053 (UMLS CUI [3])
C0003281 (UMLS CUI [4])
Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia | Cerebrovascular accident | Uncontrolled hypertension
Item
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
Study Subject Participation Status | Treatment Protocols Investigational
Item
patients on other experimental treatment protocols
boolean
C2348568 (UMLS CUI [1])
C0040808 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Primary tumor second | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix)
boolean
C0677930 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Mental disorders 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])
C0332196 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0332196 (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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