ID

26301

Description

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

Lien

https://clinicaltrials.gov/show/NCT00694200

Mots-clés

Versions (1)
  1. 16/10/2017 16/10/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 octobre 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 Breast Cancer NCT00694200

Anglais

Eligibility Breast Cancer NCT00694200

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Breast adenocarcinoma metastatic

Type de données

boolean

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

Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast

Type de données

boolean

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

Age

Type de données

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)
Description

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

Type de données

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
Description

performance status

Type de données

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
Description

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

Type de données

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)
Description

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

Type de données

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
Description

Absence Metastatic malignant neoplasm to brain Progressive

Type de données

boolean

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

Absence Metastatic malignant neoplasm to brain Without Therapeutic radiology procedure

Type de données

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
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient unable to take oral medication
Description

Lacking Able to swallow oral medication

Type de données

boolean

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

Communicable Disease

Type de données

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)
Description

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

Type de données

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
Description

Cerebrovascular accident

Type de données

boolean

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

Anticoagulation Therapy | Exception Aspirin Low Dose

Type de données

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2608320
other invasive malignancy except nonmelanoma skin cancer
Description

Invasive cancer | Exception Skin carcinoma

Type de données

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
Description

Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance

Type de données

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
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT00694200

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
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