ID

21873

Description

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

Lien

https://clinicaltrials.gov/show/NCT00415779

Mots-clés

Versions (1)
  1. 05/05/2017 05/05/2017 -
Téléchargé le

5 mai 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Metastatic Prostate Cancer NCT00415779

Anglais

Eligibility Metastatic Prostate Cancer NCT00415779

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Type de données

boolean

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

Hormone refractory prostate cancer

Type de données

boolean

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

Disease TNM clinical staging | Secondary malignant neoplasm of bone

Type de données

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
Description

Immunotherapy Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent

Type de données

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)
Description

ECOG performance status

Type de données

boolean

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

Creatinine measurement, serum

Type de données

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)
Description

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

Type de données

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)
Description

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

Type de données

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
Description

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

Type de données

boolean

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

Exclusion Criteria

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

Malignant Neoplasms | Epithelioma Treated Radical

Type de données

boolean

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

Chemotherapy

Type de données

boolean

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

Comorbidity | Medical contraindication Investigational New Drugs

Type de données

boolean

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

Diabetic - poor control

Type de données

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
Description

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

Type de données

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
Description

Communicable Disease Severe

Type de données

boolean

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

Cerebral metastasis

Type de données

boolean

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

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

Type de données

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
Retour au début de la page

Similar models

Eligibility Metastatic Prostate Cancer NCT00415779

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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