ID

30266

Descrizione

Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00687297

collegamento

https://clinicaltrials.gov/show/NCT00687297

Keywords

versioni (1)
  1. 25/05/18 25/05/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

25 maggio 2018

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00687297

Inglese

Eligibility Lung Cancer NCT00687297

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed non-small cell lung cancer
Descrizione

Non-Small Cell Lung Carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007131
advanced disease (stage iiib disease [malignant pleural or pericardial effusion seen on ct or chest x-ray, any n, m0] or stage iv disease [any t, any n, m1: distant metastases]) that is primary or recurrent
Descrizione

Advanced disease TNM clinical staging | Malignant Pleural Effusion CT | Malignant pericardial effusion CT | Malignant Pleural Effusion Chest X-ray | Malignant pericardial effusion Chest X-ray | Primary disorder TNM clinical staging | Recurrent disease TNM clinical staging

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0080032
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0220655
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0080032
UMLS CUI [4,2]
C0039985
UMLS CUI [5,1]
C0220655
UMLS CUI [5,2]
C0039985
UMLS CUI [6,1]
C0277554
UMLS CUI [6,2]
C3258246
UMLS CUI [7,1]
C0277556
UMLS CUI [7,2]
C3258246
measurable disease according to the recist criteria
Descrizione

Measurable Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status 0 or 1
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function, as evidenced by all the following
Descrizione

Organ function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0678852
absolute neutrophil count (anc) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³
Descrizione

Absolute neutrophil count | Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
hemoglobin ≥ 9 gm/dl
Descrizione

Hemoglobin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0518015
total bilirubin ≤ 1 x institutional uln; if patient has gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin ≤ 2 x institutional uln.
Descrizione

Serum total bilirubin measurement | Gilbert Disease | Hyperbilirubinemia Isolated | Abnormal Liver function tests Absent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
UMLS CUI [3,1]
C0020433
UMLS CUI [3,2]
C0205409
UMLS CUI [4,1]
C0151766
UMLS CUI [4,2]
C0332197
ast, alt and alkaline phosphatase (alk phos) must be ≤ 1.5 uln
Descrizione

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
creatinine ≤ 1.5 x institutional uln or calculated creatinine clearance ≥ 60 ml/min
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
potassium between 4 meq/l and institutional uln (supplementation may be used),
Descrizione

Serum potassium measurement | Potassium supplementation allowed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0302353
UMLS CUI [2,1]
C0561938
UMLS CUI [2,2]
C0683607
calcium (ionized or adjusted for albumin)within institutional normal limits
Descrizione

Calcium ionised normal | Calcium Corrected for albumin Normal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0855660
UMLS CUI [2,1]
C0006675
UMLS CUI [2,2]
C1439360
UMLS CUI [2,3]
C0205307
magnesium within institutional normal limits (supplementation may be used)
Descrizione

Serum magnesium normal | Magnesium supplementation allowed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0858145
UMLS CUI [2,1]
C1096534
UMLS CUI [2,2]
C0683607
no prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (prior adjuvant therapy for lung cancer allowed if completed > 1 year prior to registration)
Descrizione

Exclusion Criteria | Cytotoxic Chemotherapy Advanced disease | Targeted Therapy Advanced disease | Cytotoxic Chemotherapy Neoplasm Metastasis | Targeted Therapy Neoplasm Metastasis | Prior Adjuvant Therapy Carcinoma of lung allowed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C0679246
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0679246
UMLS CUI [4,1]
C0677881
UMLS CUI [4,2]
C0027627
UMLS CUI [5,1]
C2985566
UMLS CUI [5,2]
C0027627
UMLS CUI [6,1]
C1514456
UMLS CUI [6,2]
C0684249
UMLS CUI [6,3]
C0683607
able to take oral medication
Descrizione

Able to swallow Oral medication

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
myocardial infarction, superior vena caval syndrome, nyha classification of heart disease ≥ 2 within the 3 months prior to entry
Descrizione

Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038833
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C1275491
history of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment
Descrizione

Ventricular arrhythmia Uncontrolled Treatment required for | Ventricular arrhythmia Recurrent Treatment required for | Supraventricular arrhythmia Uncontrolled Treatment required for | Supraventricular arrhythmia Recurrent Treatment required for | Nodal rhythm disorder Uncontrolled Treatment required for | Nodal rhythm disorder Recurrent Treatment required for

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C0085612
UMLS CUI [2,2]
C2945760
UMLS CUI [2,3]
C0332121
UMLS CUI [3,1]
C0428974
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0332121
UMLS CUI [4,1]
C0428974
UMLS CUI [4,2]
C2945760
UMLS CUI [4,3]
C0332121
UMLS CUI [5,1]
C0264893
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C0332121
UMLS CUI [6,1]
C0264893
UMLS CUI [6,2]
C2945760
UMLS CUI [6,3]
C0332121
hypertension not controlled by medication
Descrizione

Uncontrolled hypertension

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1868885
peripheral or sensory neuropathy > grade 1
Descrizione

Peripheral Neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0151313
UMLS CUI [2,2]
C1516728
known hypersensitivity to carboplatin or docetaxel
Descrizione

Carboplatin allergy | Hypersensitivity Docetaxel

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0570701
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0246415
active infection
Descrizione

Communicable Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Lung Cancer NCT00687297

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Advanced disease TNM clinical staging | Malignant Pleural Effusion CT | Malignant pericardial effusion CT | Malignant Pleural Effusion Chest X-ray | Malignant pericardial effusion Chest X-ray | Primary disorder TNM clinical staging | Recurrent disease TNM clinical staging
Item
advanced disease (stage iiib disease [malignant pleural or pericardial effusion seen on ct or chest x-ray, any n, m0] or stage iv disease [any t, any n, m1: distant metastases]) that is primary or recurrent
boolean
C0679246 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0080032 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0220655 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0080032 (UMLS CUI [4,1])
C0039985 (UMLS CUI [4,2])
C0220655 (UMLS CUI [5,1])
C0039985 (UMLS CUI [5,2])
C0277554 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
C0277556 (UMLS CUI [7,1])
C3258246 (UMLS CUI [7,2])
Measurable Disease
Item
measurable disease according to the recist criteria
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function, as evidenced by all the following
boolean
C0678852 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement
Item
absolute neutrophil count (anc) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Hemoglobin measurement
Item
hemoglobin ≥ 9 gm/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement | Gilbert Disease | Hyperbilirubinemia Isolated | Abnormal Liver function tests Absent
Item
total bilirubin ≤ 1 x institutional uln; if patient has gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin ≤ 2 x institutional uln.
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
C0020433 (UMLS CUI [3,1])
C0205409 (UMLS CUI [3,2])
C0151766 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
ast, alt and alkaline phosphatase (alk phos) must be ≤ 1.5 uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine ≤ 1.5 x institutional uln or calculated creatinine clearance ≥ 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum potassium measurement | Potassium supplementation allowed
Item
potassium between 4 meq/l and institutional uln (supplementation may be used),
boolean
C0302353 (UMLS CUI [1])
C0561938 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Calcium ionised normal | Calcium Corrected for albumin Normal
Item
calcium (ionized or adjusted for albumin)within institutional normal limits
boolean
C0855660 (UMLS CUI [1])
C0006675 (UMLS CUI [2,1])
C1439360 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
Serum magnesium normal | Magnesium supplementation allowed
Item
magnesium within institutional normal limits (supplementation may be used)
boolean
C0858145 (UMLS CUI [1])
C1096534 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Exclusion Criteria | Cytotoxic Chemotherapy Advanced disease | Targeted Therapy Advanced disease | Cytotoxic Chemotherapy Neoplasm Metastasis | Targeted Therapy Neoplasm Metastasis | Prior Adjuvant Therapy Carcinoma of lung allowed
Item
no prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (prior adjuvant therapy for lung cancer allowed if completed > 1 year prior to registration)
boolean
C0680251 (UMLS CUI [1])
C0677881 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
C0677881 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C2985566 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C1514456 (UMLS CUI [6,1])
C0684249 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Able to swallow Oral medication
Item
able to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification
Item
myocardial infarction, superior vena caval syndrome, nyha classification of heart disease ≥ 2 within the 3 months prior to entry
boolean
C0027051 (UMLS CUI [1])
C0038833 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
Ventricular arrhythmia Uncontrolled Treatment required for | Ventricular arrhythmia Recurrent Treatment required for | Supraventricular arrhythmia Uncontrolled Treatment required for | Supraventricular arrhythmia Recurrent Treatment required for | Nodal rhythm disorder Uncontrolled Treatment required for | Nodal rhythm disorder Recurrent Treatment required for
Item
history of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment
boolean
C0085612 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0085612 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0332121 (UMLS CUI [2,3])
C0428974 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0332121 (UMLS CUI [3,3])
C0428974 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
C0332121 (UMLS CUI [4,3])
C0264893 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0332121 (UMLS CUI [5,3])
C0264893 (UMLS CUI [6,1])
C2945760 (UMLS CUI [6,2])
C0332121 (UMLS CUI [6,3])
Uncontrolled hypertension
Item
hypertension not controlled by medication
boolean
C1868885 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades
Item
peripheral or sensory neuropathy > grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0151313 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Carboplatin allergy | Hypersensitivity Docetaxel
Item
known hypersensitivity to carboplatin or docetaxel
boolean
C0570701 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
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