ID

31204

Beschreibung

Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01687439

Link

https://clinicaltrials.gov/show/NCT01687439

Stichworte

Versionen (1)
  1. 28.07.18 28.07.18 -
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See clinicaltrials.gov

Hochgeladen am

28. Juli 2018

DOI

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Eligibility Non-small Cell Lung Cancer NCT01687439

Englisch

Eligibility Non-small Cell Lung Cancer NCT01687439

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven inoperable stage iiib-iv nsclc
Beschreibung

Non-Small Cell Lung Carcinoma Inoperable TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C3258246
ecog ps 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate blood functions: absolute neutrophil count (anc) ≥ 1.5 x 109/l, platelet count ≥ 100 x 109/l, and hemoglobin ≥ 9 g / dl
Beschreibung

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
adequate liver function: total bilirubin <1.5 times the upper limit of normal (uln); ast and alt <2.5 times uln in patients without liver metastases, <5 times uln in patients with liver metastases
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

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
adequate renal function: serum creatinine ≤ 1.25 times uln or calculated creatinine clearance ≥ 50 ml / min and urinary protein <2+. in patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
Beschreibung

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Proteinuria | 24 hour urine sample | 24 Hour urine volume measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0033687
UMLS CUI [5]
C0456209
UMLS CUI [6]
C0427843
international normalized ratio (inr) ≤ 1.5 and prothrombin time(pt) ≤ 1.5 times uln within 7 days before enrollment
Beschreibung

International Normalized Ratio | Prothrombin time assay

Datentyp

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0033707
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of bleeding diathesis or coagulopathy
Beschreibung

Bleeding tendency | Blood Coagulation Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
history of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
Beschreibung

Hemoptysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019079
previously received chemotherapy and radiotherapy and biological targeted therapy
Beschreibung

Prior Chemotherapy | Prior radiation therapy | Targeted Therapy biological

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0205460
uncontrolled hypertension (systolic blood pressure> 150 mmhg and/or diastolic blood pressure> 100 mm hg)
Beschreibung

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (new york heart association class ≥grade ii) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
Beschreibung

Cardiovascular Diseases | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Cardiac Arrhythmia Affecting Clinical Trial | Cardiac Arrhythmia Pharmacotherapy Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0013227
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0008976
UMLS CUI [8,1]
C0003811
UMLS CUI [8,2]
C0013216
UMLS CUI [8,3]
C1272705
unhealed wounds, active peptic ulcer or fracture
Beschreibung

Wound, non-healed | Peptic Ulcer | Fracture

Datentyp

boolean

Alias
UMLS CUI [1]
C0750433
UMLS CUI [2]
C0030920
UMLS CUI [3]
C0016658
gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
Beschreibung

Digestive System Fistula | Gastrointestinal perforation | Abdominal Abscess

Datentyp

boolean

Alias
UMLS CUI [1]
C0079238
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (iud, spermicide barrier birth control device or sterilization) during the study. male who are unwilling to take effective contraceptive measures during the study
Beschreibung

Gender Uterus Intact | Menopause Excluded | Contraceptive methods Unwilling | Intrauterine Devices | Vaginal Spermicides | Contraception, Barrier | Female Sterilization | Gender Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0042149
UMLS CUI [1,3]
C0205266
UMLS CUI [2,1]
C0025320
UMLS CUI [2,2]
C0332196
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0087145
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0015787
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0700589
UMLS CUI [8,3]
C0558080
participated in other clinical trials within 28 days before the initiation of treatment.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
allergic to any of the study drugs
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT01687439

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Inoperable TNM clinical staging
Item
histologically or cytologically proven inoperable stage iiib-iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
ECOG performance status
Item
ecog ps 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate blood functions: absolute neutrophil count (anc) ≥ 1.5 x 109/l, platelet count ≥ 100 x 109/l, and hemoglobin ≥ 9 g / dl
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present
Item
adequate liver function: total bilirubin <1.5 times the upper limit of normal (uln); ast and alt <2.5 times uln in patients without liver metastases, <5 times uln in patients with liver metastases
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])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Proteinuria | 24 hour urine sample | 24 Hour urine volume measurement
Item
adequate renal function: serum creatinine ≤ 1.25 times uln or calculated creatinine clearance ≥ 50 ml / min and urinary protein <2+. in patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0033687 (UMLS CUI [4])
C0456209 (UMLS CUI [5])
C0427843 (UMLS CUI [6])
International Normalized Ratio | Prothrombin time assay
Item
international normalized ratio (inr) ≤ 1.5 and prothrombin time(pt) ≤ 1.5 times uln within 7 days before enrollment
boolean
C0525032 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bleeding tendency | Blood Coagulation Disorders
Item
evidence of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Hemoptysis
Item
history of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
boolean
C0019079 (UMLS CUI [1])
Prior Chemotherapy | Prior radiation therapy | Targeted Therapy biological
Item
previously received chemotherapy and radiotherapy and biological targeted therapy
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C2985566 (UMLS CUI [3,1])
C0205460 (UMLS CUI [3,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (systolic blood pressure> 150 mmhg and/or diastolic blood pressure> 100 mm hg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Cardiovascular Diseases | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Cardiac Arrhythmia Affecting Clinical Trial | Cardiac Arrhythmia Pharmacotherapy Unsuccessful
Item
clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (new york heart association class ≥grade ii) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0013227 (UMLS CUI [6,4])
C0003811 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0008976 (UMLS CUI [7,3])
C0003811 (UMLS CUI [8,1])
C0013216 (UMLS CUI [8,2])
C1272705 (UMLS CUI [8,3])
Wound, non-healed | Peptic Ulcer | Fracture
Item
unhealed wounds, active peptic ulcer or fracture
boolean
C0750433 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Digestive System Fistula | Gastrointestinal perforation | Abdominal Abscess
Item
gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
boolean
C0079238 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Gender Uterus Intact | Menopause Excluded | Contraceptive methods Unwilling | Intrauterine Devices | Vaginal Spermicides | Contraception, Barrier | Female Sterilization | Gender Contraceptive methods Unwilling
Item
women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (iud, spermicide barrier birth control device or sterilization) during the study. male who are unwilling to take effective contraceptive measures during the study
boolean
C0079399 (UMLS CUI [1,1])
C0042149 (UMLS CUI [1,2])
C0205266 (UMLS CUI [1,3])
C0025320 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0021900 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0015787 (UMLS CUI [7])
C0079399 (UMLS CUI [8,1])
C0700589 (UMLS CUI [8,2])
C0558080 (UMLS CUI [8,3])
Study Subject Participation Status
Item
participated in other clinical trials within 28 days before the initiation of treatment.
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs
Item
allergic to any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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