ID

14956

Beschrijving

A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00717951

Link

https://clinicaltrials.gov/show/NCT00717951

Trefwoorden

  1. 09-05-16 09-05-16 -
Geüploaded op

9 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Advanced Breast Cancer NCT00717951

Eligibility Advanced Breast Cancer NCT00717951

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age≥18y
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
kps≥ 70
Beschrijving

karnofsky

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
pathologic diagnosis of breast cancer
Beschrijving

breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
at least 1 measurable lesion as defined by modified recist criteria
Beschrijving

measurable lesion

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/l platelet:≥100×109/l creatinine clearance rate:
Beschrijving

laboratory values

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0948762
≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal alkaline phosphatase,aspartate aminotransferase and alanine aminotransferase:≤ 2.5×upper limits of normal(≤5×upper limits of normal if liver metastasis are present)
Beschrijving

lab results

Datatype

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0002059
signed informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.
Beschrijving

negative pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
Beschrijving

chemotherapy treatment

Datatype

boolean

Alias
UMLS CUI [1]
C3665472
prior exposure to 5-fluorouracil continuous infusion.
Beschrijving

5-fluorouracil

Datatype

boolean

Alias
UMLS CUI [1]
C0016360
prior exposure docetaxol for metastatic disease
Beschrijving

docetaxol for metastatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0246415
any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
Beschrijving

cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Advanced Breast Cancer NCT00717951

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age≥18y
boolean
C0001779 (UMLS CUI [1])
karnofsky
Item
kps≥ 70
boolean
C0206065 (UMLS CUI [1])
breast cancer
Item
pathologic diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
measurable lesion
Item
at least 1 measurable lesion as defined by modified recist criteria
boolean
C1513041 (UMLS CUI [1])
laboratory values
Item
screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/l platelet:≥100×109/l creatinine clearance rate:
boolean
C0019046 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
lab results
Item
≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal alkaline phosphatase,aspartate aminotransferase and alanine aminotransferase:≤ 2.5×upper limits of normal(≤5×upper limits of normal if liver metastasis are present)
boolean
C0201913 (UMLS CUI [1])
C0002059 (UMLS CUI [2])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
negative pregnancy test
Item
for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy treatment
Item
more than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
boolean
C3665472 (UMLS CUI [1])
5-fluorouracil
Item
prior exposure to 5-fluorouracil continuous infusion.
boolean
C0016360 (UMLS CUI [1])
docetaxol for metastatic disease
Item
prior exposure docetaxol for metastatic disease
boolean
C0246415 (UMLS CUI [1])
cancer
Item
any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
boolean
C0006826 (UMLS CUI [1])

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