ID

38195

Description

Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca; ODM derived from: https://clinicaltrials.gov/show/NCT02144194

Lien

https://clinicaltrials.gov/show/NCT02144194

Mots-clés

Versions (1)
  1. 26/09/2019 26/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

26 septembre 2019

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 NCT02144194

Anglais

Eligibility Breast Cancer NCT02144194

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
patients >=18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
Description

Breast adenocarcinoma metastatic Inoperable Curative intent | Breast adenocarcinoma recurrent Locally Inoperable Curative intent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1697918
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C1276305
UMLS CUI [2,1]
C0861355
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C0205187
UMLS CUI [2,4]
C1276305
measurable and/or non-measurable disease
Description

Measurable Disease | Non-Measurable Lesion

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
the patient's primary and/or metastatic tumor is her2 neu negative
Description

Primary tumor HER2/Neu Negative | Metastatic Neoplasm HER2/Neu Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2348908
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C2348908
documented metastatic disease previously untreated with palliative chemotherapy
Description

Neoplasm Metastasis | Chemotherapy Palliative Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1285530
UMLS CUI [2,3]
C0332197
adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
Description

Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | docetaxel | Chemotherapy | Disease-Free Survival Duration

Type de données

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [3]
C0246415
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C0242793
UMLS CUI [5,2]
C0449238
no symptom or sign of brain metastasis
Description

Sign or Symptom Absent Metastatic malignant neoplasm to brain

Type de données

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0220650
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
operable local recurrence
Description

Recurrence Local Operable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205188
ascites or pericardial effusion as only site of metastasis
Description

Ascites | Pericardial effusion | Site only Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0031039
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0205171
UMLS CUI [3,3]
C0027627
symptomatic peripheral neuropathy > grade 1 according to the nci common toxicity criteria
Description

Peripheral Neuropathy Symptomatic CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1516728
radiotherapy to all areas of evaluable disease within the previous 4 weeks
Description

Therapeutic radiology procedure Area Evaluable Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1516986
disease significantly affecting absorption
Description

Disease Affecting Absorption

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
severe hepatic insufficiency
Description

Hepatic Insufficiency Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0205082
patient previously treated with chemotherapy for their metastatic disease
Description

Prior Chemotherapy Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT02144194

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])
Age
Item
patients >=18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma metastatic Inoperable Curative intent | Breast adenocarcinoma recurrent Locally Inoperable Curative intent
Item
histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
boolean
C1697918 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C0861355 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0205187 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
Measurable Disease | Non-Measurable Lesion
Item
measurable and/or non-measurable disease
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
Primary tumor HER2/Neu Negative | Metastatic Neoplasm HER2/Neu Negative
Item
the patient's primary and/or metastatic tumor is her2 neu negative
boolean
C0677930 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C2939420 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Neoplasm Metastasis | Chemotherapy Palliative Absent
Item
documented metastatic disease previously untreated with palliative chemotherapy
boolean
C0027627 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1285530 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | docetaxel | Chemotherapy | Disease-Free Survival Duration
Item
adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
boolean
C0085533 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0246415 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0242793 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
Sign or Symptom Absent Metastatic malignant neoplasm to brain
Item
no symptom or sign of brain metastasis
boolean
C3540840 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0220650 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Recurrence Local Operable
Item
operable local recurrence
boolean
C0034897 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
Ascites | Pericardial effusion | Site only Neoplasm Metastasis
Item
ascites or pericardial effusion as only site of metastasis
boolean
C0003962 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C1515974 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
Peripheral Neuropathy Symptomatic CTCAE Grades
Item
symptomatic peripheral neuropathy > grade 1 according to the nci common toxicity criteria
boolean
C0031117 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Therapeutic radiology procedure Area Evaluable Disease
Item
radiotherapy to all areas of evaluable disease within the previous 4 weeks
boolean
C1522449 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1516986 (UMLS CUI [1,3])
Disease Affecting Absorption
Item
disease significantly affecting absorption
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
Hepatic Insufficiency Severe
Item
severe hepatic insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Prior Chemotherapy Neoplasm Metastasis
Item
patient previously treated with chemotherapy for their metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
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