ID

21873

Beschreibung

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00415779

Link

https://clinicaltrials.gov/show/NCT00415779

Stichworte

Versionen (1)
  1. 05.05.17 05.05.17 -
Hochgeladen am

5. Mai 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 Metastatic Prostate Cancer NCT00415779

Englisch

Eligibility Metastatic Prostate Cancer NCT00415779

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
hormone refractory prostate cancer
Beschreibung

Hormone refractory prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C1328504
stage iv disease with bone metastasis
Beschreibung

Disease TNM clinical staging | Secondary malignant neoplasm of bone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0153690
no immunotherapy, hormonal therapy or radiotherapy within the previous month
Beschreibung

Immunotherapy Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
performance status < or = 2 (ecog)
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine < 1.5 mg/100ml
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin < or = 1.25 x unl (upper normal limit) (or < or = 1.5 x unl in the presence of hepatic metastases); sgot e sgpt < or = 1.5 x unl (or < or = 2.5 x unl in presence of hepatic metastases)
Beschreibung

Serum total bilirubin measurement | Secondary malignant neoplasm of liver | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0494165
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or muga scan)
Beschreibung

Left ventricular ejection fraction Cardiac ultrasound | Left ventricular ejection fraction Multiple gated acquisition scanning

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C1655737
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· life expectancy of at least 3 months
Beschreibung

Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous malignancies with the exception of radically treated epithelioma
Beschreibung

Malignant Neoplasms | Epithelioma Treated Radical

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0553707
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0439807
previous chemotherapy
Beschreibung

Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
comorbidities that would, in the investigator's opinion, contraindicate the use of the drugs in the study
Beschreibung

Comorbidity | Medical contraindication Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
uncontrolled diabetes
Beschreibung

Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months
Beschreibung

Cardiac Arrhythmia Severe | Congestive heart failure Uncontrolled Severe | Myocardial Ischemia Severe | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0027051
severe infection
Beschreibung

Communicable Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
cerebral metastasis
Beschreibung

Cerebral metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0555278
pre-existing motor or sensory neurotoxicity > or = grade 2 according to ctc (common toxicity criteria).
Beschreibung

Neurotoxicity Motor Pre-existing CTCAE Grades | Neurotoxicity Sensory Pre-existing CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0501384
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C0235032
UMLS CUI [2,2]
C0501385
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C1516728
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Metastatic Prostate Cancer NCT00415779

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Hormone refractory prostate cancer
Item
hormone refractory prostate cancer
boolean
C1328504 (UMLS CUI [1])
Disease TNM clinical staging | Secondary malignant neoplasm of bone
Item
stage iv disease with bone metastasis
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
Immunotherapy Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent
Item
no immunotherapy, hormonal therapy or radiotherapy within the previous month
boolean
C0021083 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status
Item
performance status < or = 2 (ecog)
boolean
C1520224 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 mg/100ml
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Secondary malignant neoplasm of liver | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum bilirubin < or = 1.25 x unl (upper normal limit) (or < or = 1.5 x unl in the presence of hepatic metastases); sgot e sgpt < or = 1.5 x unl (or < or = 2.5 x unl in presence of hepatic metastases)
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Left ventricular ejection fraction Cardiac ultrasound | Left ventricular ejection fraction Multiple gated acquisition scanning
Item
left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or muga scan)
boolean
C0428772 (UMLS CUI [1,1])
C1655737 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Life Expectancy
Item
neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· life expectancy of at least 3 months
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0023671 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Epithelioma Treated Radical
Item
previous malignancies with the exception of radically treated epithelioma
boolean
C0006826 (UMLS CUI [1])
C0553707 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0439807 (UMLS CUI [2,3])
Chemotherapy
Item
previous chemotherapy
boolean
C0392920 (UMLS CUI [1])
Comorbidity | Medical contraindication Investigational New Drugs
Item
comorbidities that would, in the investigator's opinion, contraindicate the use of the drugs in the study
boolean
C0009488 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Cardiac Arrhythmia Severe | Congestive heart failure Uncontrolled Severe | Myocardial Ischemia Severe | Myocardial Infarction
Item
severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months
boolean
C0003811 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0151744 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
Communicable Disease Severe
Item
severe infection
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cerebral metastasis
Item
cerebral metastasis
boolean
C0555278 (UMLS CUI [1])
Neurotoxicity Motor Pre-existing CTCAE Grades | Neurotoxicity Sensory Pre-existing CTCAE Grades
Item
pre-existing motor or sensory neurotoxicity > or = grade 2 according to ctc (common toxicity criteria).
boolean
C0235032 (UMLS CUI [1,1])
C0501384 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0235032 (UMLS CUI [2,1])
C0501385 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
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