ID

30266

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00687297

Nyckelord

Versioner (1)
  1. 2018-05-25 2018-05-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 maj 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Lung Cancer NCT00687297

Engelsk

Eligibility Lung Cancer NCT00687297

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Measurable Disease

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Organ function

Datatyp

boolean

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

Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

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

Hemoglobin measurement

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Serum potassium measurement | Potassium supplementation allowed

Datatyp

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
Beskrivning

Calcium ionised normal | Calcium Corrected for albumin Normal

Datatyp

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)
Beskrivning

Serum magnesium normal | Magnesium supplementation allowed

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Able to swallow Oral medication

Datatyp

boolean

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

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

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

Peripheral Neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades

Datatyp

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
Beskrivning

Carboplatin allergy | Hypersensitivity Docetaxel

Datatyp

boolean

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

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
Tillbaka till toppen

Similar models

Eligibility Lung Cancer NCT00687297

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial