ID

27418

Beschreibung

Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00625352

Link

https://clinicaltrials.gov/show/NCT00625352

Stichworte

Versionen (1)
  1. 14.11.17 14.11.17 -
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See clinicaltrials.gov

Hochgeladen am

14. November 2017

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00625352

Englisch

Eligibility Carcinoma, Non-Small-Cell Lung NCT00625352

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically- or cytologically- confirmed non-small-cell lung cancer stage iiib/iv
Beschreibung

Non-Small Cell Lung Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
no prior chemotherapy
Beschreibung

Prior Chemotherapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
existence of measurable disease. the measurable disease should not have been irradiated
Beschreibung

Measurable Disease | Therapeutic radiology procedure Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
life expectancy of more than 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
age ≥ 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status (ecog):1 or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function (absolute neutrophil count >1500/mm^3, platelet count>100000/mm^3, hemoglobin>9gr/mm^3)
Beschreibung

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
adequate liver (bilirubin<2 times upper limit of normal and sgot/sgpt<3 times upper limit of normal) and renal function (creatinine<1.5mg/dl)
Beschreibung

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
psychiatric illness or social situation that would preclude study compliance.
Beschreibung

Mental disorder Excludes Protocol Compliance | Social situation Excludes Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
other concurrent uncontrolled illness.
Beschreibung

Illness Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Beschreibung

Invasive cancer | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
currently/recently taken warfarin, phenprocoumon or phenytoin
Beschreibung

Warfarin | Phenprocoumon | Phenytoin

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0031444
UMLS CUI [3]
C0031507
hypersensitivity history to any drug
Beschreibung

Drug Allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small-Cell Lung NCT00625352

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically- or cytologically- confirmed non-small-cell lung cancer stage iiib/iv
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prior Chemotherapy Absent
Item
no prior chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease | Therapeutic radiology procedure Absent
Item
existence of measurable disease. the measurable disease should not have been irradiated
boolean
C1513041 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
age ≥ 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status (ecog):1 or 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow function (absolute neutrophil count >1500/mm^3, platelet count>100000/mm^3, hemoglobin>9gr/mm^3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin<2 times upper limit of normal and sgot/sgpt<3 times upper limit of normal) and renal function (creatinine<1.5mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorder Excludes Protocol Compliance | Social situation Excludes Protocol Compliance
Item
psychiatric illness or social situation that would preclude study compliance.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Illness Uncontrolled
Item
other concurrent uncontrolled illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Invasive cancer | Exception Skin carcinoma
Item
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Warfarin | Phenprocoumon | Phenytoin
Item
currently/recently taken warfarin, phenprocoumon or phenytoin
boolean
C0043031 (UMLS CUI [1])
C0031444 (UMLS CUI [2])
C0031507 (UMLS CUI [3])
Drug Allergy
Item
hypersensitivity history to any drug
boolean
C0013182 (UMLS CUI [1])
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