ID

19692

Beschreibung

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

Stichworte

Versionen (1)
  1. 22.01.17 22.01.17 -
Hochgeladen am

22. Januar 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Neoplasms NCT00324610

Englisch

Eligibility Breast Neoplasms NCT00324610

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven breast adenocarcinoma
Beschreibung

Breast adenocarcinoma

Datentyp

boolean

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

Measurable Disease | Evaluable Disease

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Anthracyclines | taxane

Datentyp

boolean

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

Age

Datentyp

boolean

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

Chemotherapy Regimen Quantity Neoplasm Metastasis

Datentyp

boolean

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

Central Nervous System Involvement

Datentyp

boolean

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

Hormone Therapy To be stopped

Datentyp

boolean

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

Biological function

Datentyp

boolean

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

performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

boolean

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

Gastrointestinal Disease Affecting Absorption capecitabine

Datentyp

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
Beschreibung

Heart failure Uncontrolled | Angina Pectoris Uncontrolled

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Dihydropyrimidine Dehydrogenase Deficiency

Datentyp

boolean

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

cancer treatment | Hormone Therapy

Datentyp

boolean

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

Therapeutic radiology procedure

Datentyp

boolean

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

sorivudine | sorivudine Analog

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Study Subject Participation Status | research study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Neoplasms NCT00324610

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video