ID

19692

Description

Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT00324610

Link

https://clinicaltrials.gov/show/NCT00324610

Keywords

Versions (1)
  1. 1/22/17 1/22/17 -
Uploaded on

January 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00324610

English

Eligibility Breast Neoplasms NCT00324610

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven breast adenocarcinoma
Description

Breast adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
evaluable or measurable metastases
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
her-2 status 0 or 1 in immnohistochimy or negative in fish/cish
Description

HER2/Neu Status Immunohistochemistry | HER2/Neu Negative Fluorescent in Situ Hybridization | HER2/Neu Negative Chromogenic in situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C2348908
UMLS CUI [2,2]
C0162789
UMLS CUI [3,1]
C2348908
UMLS CUI [3,2]
C1516514
previously treated with anthracyclines and taxanes
Description

Anthracyclines | taxane

Data type

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0215136
age > = 18 y
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no more than two previous chemotherapy regimens for metastases
Description

Chemotherapy Regimen Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
no nervous central system involvement
Description

Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1]
C4050309
hormonal therapy must have been stopped two weeks before enrollment
Description

Hormone Therapy To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1272691
adequate biologic function
Description

Biological function

Data type

boolean

Alias
UMLS CUI [1]
C3714634
performance status oms < = 2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of other malignancies, except basocellular cancer, in situ cervix carcinoma
Description

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
gastro intestinal disease that might affect absorption of capecitabine
Description

Gastrointestinal Disease Affecting Absorption capecitabine

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2347023
UMLS CUI [1,4]
C0671970
cardiac failure or angina pectoris uncontrolled
Description

Heart failure Uncontrolled | Angina Pectoris Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
hypersensitivity for capecitabine, fluorouracil, or one of their excipient
Description

Hypersensitivity capecitabine | Fluorouracil allergy | Hypersensitivity capecitabine Excipient | Hypersensitivity Fluorouracil Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0671970
UMLS CUI [2]
C0570698
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0671970
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0016360
UMLS CUI [4,3]
C0015237
known dihydropyrimidine dehydrogenase (dpd) deficiency
Description

Dihydropyrimidine Dehydrogenase Deficiency

Data type

boolean

Alias
UMLS CUI [1]
C1959620
concomitant anticancer therapy (included hormonotherapy)
Description

cancer treatment | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0279025
concomitant radiotherapy
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
treatment with sorivudine and analogs
Description

sorivudine | sorivudine Analog

Data type

boolean

Alias
UMLS CUI [1]
C0207628
UMLS CUI [2,1]
C0207628
UMLS CUI [2,2]
C0243071
pregnant or breast feeding patients. contraception methods excluding hormonal treatment is required.
Description

Pregnancy | Breast Feeding | Contraceptive methods Patient need for | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0686904
UMLS CUI [4]
C0279025
inclusion in an experimental protocol within 30 days
Description

Study Subject Participation Status | research study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
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Similar models

Eligibility Breast Neoplasms NCT00324610

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma
Item
histologically proven breast adenocarcinoma
boolean
C0858252 (UMLS CUI [1])
Measurable Disease | Evaluable Disease
Item
evaluable or measurable metastases
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
HER2/Neu Status Immunohistochemistry | HER2/Neu Negative Fluorescent in Situ Hybridization | HER2/Neu Negative Chromogenic in situ Hybridization
Item
her-2 status 0 or 1 in immnohistochimy or negative in fish/cish
boolean
C1512413 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C2348908 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C2348908 (UMLS CUI [3,1])
C1516514 (UMLS CUI [3,2])
Anthracyclines | taxane
Item
previously treated with anthracyclines and taxanes
boolean
C0282564 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
Age
Item
age > = 18 y
boolean
C0001779 (UMLS CUI [1])
Chemotherapy Regimen Quantity Neoplasm Metastasis
Item
no more than two previous chemotherapy regimens for metastases
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Central Nervous System Involvement
Item
no nervous central system involvement
boolean
C4050309 (UMLS CUI [1])
Hormone Therapy To be stopped
Item
hormonal therapy must have been stopped two weeks before enrollment
boolean
C0279025 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Biological function
Item
adequate biologic function
boolean
C3714634 (UMLS CUI [1])
performance status
Item
performance status oms < = 2
boolean
C1518965 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
history of other malignancies, except basocellular cancer, in situ cervix carcinoma
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Gastrointestinal Disease Affecting Absorption capecitabine
Item
gastro intestinal disease that might affect absorption of capecitabine
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2347023 (UMLS CUI [1,3])
C0671970 (UMLS CUI [1,4])
Heart failure Uncontrolled | Angina Pectoris Uncontrolled
Item
cardiac failure or angina pectoris uncontrolled
boolean
C0018801 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Hypersensitivity capecitabine | Fluorouracil allergy | Hypersensitivity capecitabine Excipient | Hypersensitivity Fluorouracil Excipient
Item
hypersensitivity for capecitabine, fluorouracil, or one of their excipient
boolean
C0020517 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
C0570698 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0671970 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0016360 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Dihydropyrimidine Dehydrogenase Deficiency
Item
known dihydropyrimidine dehydrogenase (dpd) deficiency
boolean
C1959620 (UMLS CUI [1])
cancer treatment | Hormone Therapy
Item
concomitant anticancer therapy (included hormonotherapy)
boolean
C0920425 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Therapeutic radiology procedure
Item
concomitant radiotherapy
boolean
C1522449 (UMLS CUI [1])
sorivudine | sorivudine Analog
Item
treatment with sorivudine and analogs
boolean
C0207628 (UMLS CUI [1])
C0207628 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Contraceptive methods Patient need for | Hormone Therapy
Item
pregnant or breast feeding patients. contraception methods excluding hormonal treatment is required.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4])
Study Subject Participation Status | research study
Item
inclusion in an experimental protocol within 30 days
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2])
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