ID

16587

Beskrivning

A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00214864

Länk

https://clinicaltrials.gov/show/NCT00214864

Nyckelord

  1. 2016-07-25 2016-07-25 -
Uppladdad den

25 juli 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT00214864

Eligibility Metastatic Breast Cancer NCT00214864

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with histopathologically proven metastatic breast cancer.
Beskrivning

metastatic breast cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0278488
patients 18-75 years old
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status: karnofsky > 70%
Beskrivning

performance status karnofsky

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
patients must have measurable disease. patients with only blastic bone lesions are ineligible.
Beskrivning

measurable disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
adequate bone marrow, liver, renal and cardiac functions defined as:
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
ability to understand the study and give informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-fu or taxol given as part of an adjuvant regimen will not render the patient ineligible.
Beskrivning

prior chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
Beskrivning

patients with brain metastasis, adequately treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332154
patients who have received any anti-cancer investigational agent in the month prior to inclusion.
Beskrivning

received any anti-cancer investigational agent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0013230
patients previously treated with docetaxel(taxotere)or capecitabine (xeloda).
Beskrivning

previously treated with docetaxel(taxotere)or capecitabine (xeloda)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C0796483
patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
Beskrivning

GIT function, dysphagia, malabsorption

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0516983
UMLS CUI [1,2]
C0011168
UMLS CUI [1,3]
C0024523
patients with renal impairment (creatinine clearance below 30 ml/min calculated according to cockcroft and gault, see appendix d), since capecitabine is contraindicated in patients with severe renal impairment.
Beskrivning

renal impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C0151746

Similar models

Eligibility Metastatic Breast Cancer NCT00214864

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
metastatic breast cancer
Item
female patients with histopathologically proven metastatic breast cancer.
boolean
C0278488 (UMLS CUI [1])
age
Item
patients 18-75 years old
boolean
C0001779 (UMLS CUI [1])
performance status karnofsky
Item
performance status: karnofsky > 70%
boolean
C0206065 (UMLS CUI [1])
measurable disease
Item
patients must have measurable disease. patients with only blastic bone lesions are ineligible.
boolean
C1513041 (UMLS CUI [1])
comorbidity
Item
adequate bone marrow, liver, renal and cardiac functions defined as:
boolean
C0009488 (UMLS CUI [1])
informed consent
Item
ability to understand the study and give informed consent.
boolean
C0021430 (UMLS CUI [1])
prior chemotherapy
Item
patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-fu or taxol given as part of an adjuvant regimen will not render the patient ineligible.
boolean
C1514457 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
patients with brain metastasis, adequately treated
Item
patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
boolean
C0220650 (UMLS CUI [1,1])
C0332154 (UMLS CUI [1,2])
received any anti-cancer investigational agent
Item
patients who have received any anti-cancer investigational agent in the month prior to inclusion.
boolean
C0920425 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
previously treated with docetaxel(taxotere)or capecitabine (xeloda)
Item
patients previously treated with docetaxel(taxotere)or capecitabine (xeloda).
boolean
C2114510 (UMLS CUI [1,1])
C0796483 (UMLS CUI [1,2])
GIT function, dysphagia, malabsorption
Item
patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
boolean
C0516983 (UMLS CUI [1,1])
C0011168 (UMLS CUI [1,2])
C0024523 (UMLS CUI [1,3])
renal impairment
Item
patients with renal impairment (creatinine clearance below 30 ml/min calculated according to cockcroft and gault, see appendix d), since capecitabine is contraindicated in patients with severe renal impairment.
boolean
C0151746 (UMLS CUI [1])

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