ID

13388

Beschrijving

Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00041470

Link

https://clinicaltrials.gov/show/NCT00041470

Trefwoorden

  1. 10-02-16 10-02-16 -
Geüploaded op

10 februari 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00041470

Eligibility Breast Cancer NCT00041470

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Have stage iv carcinoma of the breast that has been microscopically confirmed
Beschrijving

breast carcinoma stage IV

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0278488
Be age > 18
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Be fully active or ambulatory with symptoms but able to do light work
Beschrijving

fully active

Datatype

boolean

Alias
UMLS CUI [1]
C1828078
Have a life expectancy of > 16 weeks
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin c or nitrosureas) and > 2 weeks from prior hormonal therapy
Beschrijving

prior cancer theraypy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0332152
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0279025
Have had one or less prior regimens for metastatic disease
Beschrijving

prior regimens for metastatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0392920
Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated
Beschrijving

evaluable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases
Beschrijving

uncontrolled metastases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0024109
UMLS CUI [3,1]
C0279130
UMLS CUI [3,2]
C0205318
Are medically unstable
Beschrijving

medically unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0443343
Are pregnant, nursing or unwilling to employ adequate contraception
Beschrijving

pregnancy and contraceptive use

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1999124
Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer
Beschrijving

peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2985739
Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol
Beschrijving

compliance factors

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0814423
UMLS CUI [2,2]
C1522577
Have hypersensitivity to e. coli-derived proteins, filgrastim, or any of its components
Beschrijving

hypersensitivity to ecoli-derived proteins

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C1441547
UMLS CUI [1,4]
C0014834
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0210630
Have had prior therapy with navelbine
Beschrijving

prior therapy with navelbine

Datatype

boolean

Alias
UMLS CUI [1]
C0131965

Similar models

Eligibility Breast Cancer NCT00041470

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
breast carcinoma stage IV
Item
Have stage iv carcinoma of the breast that has been microscopically confirmed
boolean
C0027651 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,3])
age
Item
Be age > 18
boolean
C0001779 (UMLS CUI [1])
fully active
Item
Be fully active or ambulatory with symptoms but able to do light work
boolean
C1828078 (UMLS CUI [1])
life expectancy
Item
Have a life expectancy of > 16 weeks
boolean
C0023671 (UMLS CUI [1])
prior cancer theraypy
Item
Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin c or nitrosureas) and > 2 weeks from prior hormonal therapy
boolean
C1272706 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
prior regimens for metastatic disease
Item
Have had one or less prior regimens for metastatic disease
boolean
C0027627 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
evaluable disease
Item
Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated
boolean
C1513041 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
uncontrolled metastases
Item
Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases
boolean
C0027627 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0279130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
medically unstable
Item
Are medically unstable
boolean
C0443343 (UMLS CUI [1])
pregnancy and contraceptive use
Item
Are pregnant, nursing or unwilling to employ adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1999124 (UMLS CUI [3])
peripheral neuropathy
Item
Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer
boolean
C0031117 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
compliance factors
Item
Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0814423 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
hypersensitivity to ecoli-derived proteins
Item
Have hypersensitivity to e. coli-derived proteins, filgrastim, or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1441547 (UMLS CUI [1,3])
C0014834 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0210630 (UMLS CUI [2,2])
prior therapy with navelbine
Item
Have had prior therapy with navelbine
boolean
C0131965 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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