ID

19743

Beschreibung

Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00281021

Link

https://clinicaltrials.gov/show/NCT00281021

Stichworte

Versionen (1)
  1. 25.01.17 25.01.17 -
Hochgeladen am

25. Januar 2017

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small Cell Lung NCT00281021

Englisch

Eligibility Carcinoma, Non-Small Cell Lung NCT00281021

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of non-small cell lung cancer
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
measurable or evaluable disease
Beschreibung

Measurable Disease | Evaluable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
primary tumor must be documented by histopathic analysis
Beschreibung

primary tumor Histopathology finding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0428093
disease recurrences occurring greater than five years after original diagnosis must be biopsy proven
Beschreibung

Disease recurrence Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679254
UMLS CUI [1,2]
C0005558
treatment with only one prior chemotherapy regimen for advanced disease (one additional prior regimen was allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy)
Beschreibung

Chemotherapy Regimen Quantity advanced disease | Neoadjuvant Therapy | Adjuvant therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
UMLS CUI [2]
C0600558
UMLS CUI [3]
C0677850
serum creatinine < 2mg/dl, or a calculated creatinine clearance > 40cc/min using the following formula: (140-age) x wt(kg) x 0.85 (if female 0.72) x creatinine (mg/dl). tests must be done within 28 days prior to registration
Beschreibung

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
must have a ct scan (chest & abdomen) within 4 weeks prior to registration
Beschreibung

CT of chest and abdomen

Datentyp

boolean

Alias
UMLS CUI [1]
C1630402
zubrod performance status of 0-3
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or nursing
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no other prior malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Beschreibung

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Malignant Neoplasm In complete remission TNM clinical staging | Malignant Neoplasm Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0677874
UMLS CUI [5,3]
C3258246
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
history of ventricular fibrillation, sinus node or av nodal disease, wolff parkinson white syndrome, evidence of congestive heart failure, chest pain with exertion, hemodynamically significant or life threatening cardiac arrhythmia, or evidence of prior myocardial infarction on ekg. ekg must have been done within 28 days prior to registration. a normal cardiac stress test within 182 days prior to registration is required for all patients over 50 years old or those with abnormal ekg or any history of cardiac disease.
Beschreibung

Ventricular Fibrillation | Sinus Node Dysfunction | Atrioventricular node Disease | Wolff-Parkinson-White Syndrome | Congestive heart failure Evidence of | Chest pain on exertion | Cardiac Arrhythmia Hemodynamic Significant | Cardiac Arrhythmia Life Threatening | Electrocardiogram: myocardial infarction Evidence of | Cardiac stress test normal | Age | Electrocardiogram abnormal | Heart Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0042510
UMLS CUI [2]
C0428908
UMLS CUI [3,1]
C1269553
UMLS CUI [3,2]
C0012634
UMLS CUI [4]
C0043202
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0332120
UMLS CUI [6]
C0232288
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0019010
UMLS CUI [7,3]
C0750502
UMLS CUI [8,1]
C0003811
UMLS CUI [8,2]
C2826244
UMLS CUI [9,1]
C0428953
UMLS CUI [9,2]
C0332120
UMLS CUI [10]
C1096370
UMLS CUI [11]
C0001779
UMLS CUI [12]
C0522055
UMLS CUI [13]
C0018799
hypersensitivity to erlotinib and/or digoxin
Beschreibung

Hypersensitivity erlotinib | Digoxin allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
UMLS CUI [2]
C0571956
abnormal levels of k, mg, and/or ca, or conditions which cause such abnormalities (e.g. malnutrition, severe diarrhea, prolonged vomiting, dialysis, gi suction, untreated hypothyroidism, and use of diuretics, amphotericin b, steroids, or antacids)
Beschreibung

Blood potassium abnormal | abnormal; blood level, magnesium | Blood calcium abnormal | Malnutrition | Severe diarrhea | Vomiting Prolonged | Dialysis | Suction gastrointestinal | Hypothyroidism untreated | Diuretics | Amphotericin B | Steroids | Antacids

Datentyp

boolean

Alias
UMLS CUI [1]
C0853759
UMLS CUI [2]
C0476333
UMLS CUI [3]
C0853772
UMLS CUI [4]
C0162429
UMLS CUI [5]
C1443924
UMLS CUI [6,1]
C0042963
UMLS CUI [6,2]
C0439590
UMLS CUI [7]
C0011946
UMLS CUI [8,1]
C0038638
UMLS CUI [8,2]
C0521362
UMLS CUI [9]
C2749407
UMLS CUI [10]
C0012798
UMLS CUI [11]
C0002679
UMLS CUI [12]
C0038317
UMLS CUI [13]
C0003138
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Ähnliche Modelle

Eligibility Carcinoma, Non-Small Cell Lung NCT00281021

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
diagnosis of non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
primary tumor Histopathology finding
Item
primary tumor must be documented by histopathic analysis
boolean
C0677930 (UMLS CUI [1,1])
C0428093 (UMLS CUI [1,2])
Disease recurrence Biopsy
Item
disease recurrences occurring greater than five years after original diagnosis must be biopsy proven
boolean
C0679254 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity advanced disease | Neoadjuvant Therapy | Adjuvant therapy
Item
treatment with only one prior chemotherapy regimen for advanced disease (one additional prior regimen was allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy)
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
serum creatinine < 2mg/dl, or a calculated creatinine clearance > 40cc/min using the following formula: (140-age) x wt(kg) x 0.85 (if female 0.72) x creatinine (mg/dl). tests must be done within 28 days prior to registration
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
CT of chest and abdomen
Item
must have a ct scan (chest & abdomen) within 4 weeks prior to registration
boolean
C1630402 (UMLS CUI [1])
Zubrod Performance Status
Item
zubrod performance status of 0-3
boolean
C3714786 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Malignant Neoplasm In complete remission TNM clinical staging | Malignant Neoplasm Disease Free of
Item
no other prior malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5,1])
C0677874 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C0006826 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
Ventricular Fibrillation | Sinus Node Dysfunction | Atrioventricular node Disease | Wolff-Parkinson-White Syndrome | Congestive heart failure Evidence of | Chest pain on exertion | Cardiac Arrhythmia Hemodynamic Significant | Cardiac Arrhythmia Life Threatening | Electrocardiogram: myocardial infarction Evidence of | Cardiac stress test normal | Age | Electrocardiogram abnormal | Heart Diseases
Item
history of ventricular fibrillation, sinus node or av nodal disease, wolff parkinson white syndrome, evidence of congestive heart failure, chest pain with exertion, hemodynamically significant or life threatening cardiac arrhythmia, or evidence of prior myocardial infarction on ekg. ekg must have been done within 28 days prior to registration. a normal cardiac stress test within 182 days prior to registration is required for all patients over 50 years old or those with abnormal ekg or any history of cardiac disease.
boolean
C0042510 (UMLS CUI [1])
C0428908 (UMLS CUI [2])
C1269553 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0043202 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0332120 (UMLS CUI [5,2])
C0232288 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0019010 (UMLS CUI [7,2])
C0750502 (UMLS CUI [7,3])
C0003811 (UMLS CUI [8,1])
C2826244 (UMLS CUI [8,2])
C0428953 (UMLS CUI [9,1])
C0332120 (UMLS CUI [9,2])
C1096370 (UMLS CUI [10])
C0001779 (UMLS CUI [11])
C0522055 (UMLS CUI [12])
C0018799 (UMLS CUI [13])
Hypersensitivity erlotinib | Digoxin allergy
Item
hypersensitivity to erlotinib and/or digoxin
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
C0571956 (UMLS CUI [2])
Blood potassium abnormal | abnormal; blood level, magnesium | Blood calcium abnormal | Malnutrition | Severe diarrhea | Vomiting Prolonged | Dialysis | Suction gastrointestinal | Hypothyroidism untreated | Diuretics | Amphotericin B | Steroids | Antacids
Item
abnormal levels of k, mg, and/or ca, or conditions which cause such abnormalities (e.g. malnutrition, severe diarrhea, prolonged vomiting, dialysis, gi suction, untreated hypothyroidism, and use of diuretics, amphotericin b, steroids, or antacids)
boolean
C0853759 (UMLS CUI [1])
C0476333 (UMLS CUI [2])
C0853772 (UMLS CUI [3])
C0162429 (UMLS CUI [4])
C1443924 (UMLS CUI [5])
C0042963 (UMLS CUI [6,1])
C0439590 (UMLS CUI [6,2])
C0011946 (UMLS CUI [7])
C0038638 (UMLS CUI [8,1])
C0521362 (UMLS CUI [8,2])
C2749407 (UMLS CUI [9])
C0012798 (UMLS CUI [10])
C0002679 (UMLS CUI [11])
C0038317 (UMLS CUI [12])
C0003138 (UMLS CUI [13])
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