ID

26301

Beschreibung

Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00694200

Link

https://clinicaltrials.gov/show/NCT00694200

Stichworte

Versionen (1)
  1. 16.10.17 16.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Oktober 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT00694200

Englisch

Eligibility Breast Cancer NCT00694200

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically- or cytologically- confirmed metastatic breast adenocarcinoma
Beschreibung

Breast adenocarcinoma metastatic

Datentyp

boolean

Alias
UMLS CUI [1]
C1697918
at least one previous chemotherapy regimen for metastatic breast cancer
Beschreibung

Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
age 18-75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
Beschreibung

Measurable Disease | Measurable lesion Quantity | Exception Secondary malignant neoplasm of bone | Exception Ascites | Exception Pleural effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0153690
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003962
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0032227
performance status (who) 0-2
Beschreibung

performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
adequate liver function(serum bilirubin <1.5 times the upper normal limit, ast and alt <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine <1.5 times the upper normal limit) and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
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 | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

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
UMLS CUI [7]
C0232804
UMLS CUI [8]
C0201976
UMLS CUI [9,1]
C0005953
UMLS CUI [9,2]
C0031843
UMLS CUI [10]
C0948762
UMLS CUI [11]
C0032181
no radiation of measurable disease (except brain metastases)
Beschreibung

Therapeutic radiology procedure Absent Measurable Disease | Exception Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1513041
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
no progressive brain metastases according to clinical or radiological criteria
Beschreibung

Absence Metastatic malignant neoplasm to brain Progressive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0220650
UMLS CUI [1,3]
C0205329
no brain metastases without prior radiation therapy
Beschreibung

Absence Metastatic malignant neoplasm to brain Without Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0220650
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C1522449
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient unable to take oral medication
Beschreibung

Lacking Able to swallow oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
active infection
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Beschreibung

Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
history of stroke
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
anticoagulation therapy (except of low dose aspirin <325mg)
Beschreibung

Anticoagulation Therapy | Exception Aspirin Low Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2608320
other invasive malignancy 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
psychiatric illness or social situation that would preclude study compliance
Beschreibung

Mental disorders Exclude 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
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00694200

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma metastatic
Item
histologically- or cytologically- confirmed metastatic breast adenocarcinoma
boolean
C1697918 (UMLS CUI [1])
Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast
Item
at least one previous chemotherapy regimen for metastatic breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Age
Item
age 18-75 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease | Measurable lesion Quantity | Exception Secondary malignant neoplasm of bone | Exception Ascites | Exception Pleural effusion
Item
measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
boolean
C1513041 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0153690 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0003962 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0032227 (UMLS CUI [5,2])
performance status
Item
performance status (who) 0-2
boolean
C1518965 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate liver function(serum bilirubin <1.5 times the upper normal limit, ast and alt <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine <1.5 times the upper normal limit) and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
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])
C0232804 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C0031843 (UMLS CUI [9,2])
C0948762 (UMLS CUI [10])
C0032181 (UMLS CUI [11])
Therapeutic radiology procedure Absent Measurable Disease | Exception Metastatic malignant neoplasm to brain
Item
no radiation of measurable disease (except brain metastases)
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
Absence Metastatic malignant neoplasm to brain Progressive
Item
no progressive brain metastases according to clinical or radiological criteria
boolean
C0332197 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
Absence Metastatic malignant neoplasm to brain Without Therapeutic radiology procedure
Item
no brain metastases without prior radiation therapy
boolean
C0332197 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lacking Able to swallow oral medication
Item
patient unable to take oral medication
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Anticoagulation Therapy | Exception Aspirin Low Dose
Item
anticoagulation therapy (except of low dose aspirin <325mg)
boolean
C0003281 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2608320 (UMLS CUI [2,2])
Invasive cancer | Exception Skin carcinoma
Item
other invasive malignancy except nonmelanoma skin cancer
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Mental disorders Exclude 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])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video