ID

16326

Description

Gemcitabine + Carboplatin in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00450762

Link

https://clinicaltrials.gov/show/NCT00450762

Keywords

Versions (1)
  1. 7/11/16 7/11/16 -
Uploaded on

July 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00450762

English

Eligibility Breast Cancer NCT00450762

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic breast cancer
Description

metastatic breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0278488
all patients were required to give written informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
Description

Previous treatment

Data type

boolean

Alias
UMLS CUI [1]
C2114510
patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
Description

Measurable lesion outside a previous radiation port

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1282506
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status ≥ 70 %
Description

karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
minimal life expectancy of 12 weeks
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate haematological, renal, cardiac and hepatic function:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
1. leukocyte count ≥ 3.0 x 109/l
Description

leukocyte count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
2. absolute neutrophil count ≥ 2.0 x 109/l
Description

absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
3. platelet count ≥ 100 x 109/l
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
4. haemoglobin ≥ 8 g/dl
Description

haemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0518015
5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln
Description

total serum bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0494165
6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln
Description

transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
UMLS CUI [2]
C0494165
7. alkaline phosphatase level ≤ 2.5 x uln
Description

alkaline phosphatase level

Data type

boolean

Alias
UMLS CUI [1]
C1272113
8. creatinine clearance was required to exceed 60 ml/min.
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with gemcitabine or platinum agents
Description

Gemcitabine or platinum agents

Data type

boolean

Alias
UMLS CUI [1]
C0045093
UMLS CUI [2]
C2266918
inadequate creatinine clearance (< 60 ml/min)
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
only bone metastases
Description

bone metastases

Data type

boolean

Alias
UMLS CUI [1]
C0153690
symptomatic brain metastases
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
women who are pregnant, lactating or refuse effective contraception
Description

women who are pregnant, lactating or refuse effective contraception

Data type

boolean

Alias
UMLS CUI [1]
C0425965
UMLS CUI [2]
C0549206
UMLS CUI [3]
C2828358
secondary malignancy
Description

secondary malignancy

Data type

boolean

Alias
UMLS CUI [1]
C3266877
history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
Description

another primary malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0751623
active infection
Description

active infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
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Similar models

Eligibility Breast Cancer NCT00450762

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
metastatic breast cancer
Item
histologically confirmed metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
informed consent
Item
all patients were required to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Previous treatment
Item
prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
boolean
C2114510 (UMLS CUI [1])
Measurable lesion outside a previous radiation port
Item
patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
boolean
C1513041 (UMLS CUI [1,1])
C1282506 (UMLS CUI [1,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky performance status ≥ 70 %
boolean
C0206065 (UMLS CUI [1])
Life expectancy
Item
minimal life expectancy of 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
adequate haematological, renal, cardiac and hepatic function:
boolean
C0678852 (UMLS CUI [1])
leukocyte count
Item
1. leukocyte count ≥ 3.0 x 109/l
boolean
C0023508 (UMLS CUI [1])
absolute neutrophil count
Item
2. absolute neutrophil count ≥ 2.0 x 109/l
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
3. platelet count ≥ 100 x 109/l
boolean
C0005821 (UMLS CUI [1])
haemoglobin
Item
4. haemoglobin ≥ 8 g/dl
boolean
C0518015 (UMLS CUI [1])
total serum bilirubin
Item
5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
transaminases
Item
6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln
boolean
C0002594 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
alkaline phosphatase level
Item
7. alkaline phosphatase level ≤ 2.5 x uln
boolean
C1272113 (UMLS CUI [1])
creatinine clearance
Item
8. creatinine clearance was required to exceed 60 ml/min.
boolean
C0373595 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gemcitabine or platinum agents
Item
prior treatment with gemcitabine or platinum agents
boolean
C0045093 (UMLS CUI [1])
C2266918 (UMLS CUI [2])
creatinine clearance
Item
inadequate creatinine clearance (< 60 ml/min)
boolean
C0373595 (UMLS CUI [1])
bone metastases
Item
only bone metastases
boolean
C0153690 (UMLS CUI [1])
brain metastases
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
women who are pregnant, lactating or refuse effective contraception
Item
women who are pregnant, lactating or refuse effective contraception
boolean
C0425965 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
C2828358 (UMLS CUI [3])
secondary malignancy
Item
secondary malignancy
boolean
C3266877 (UMLS CUI [1])
another primary malignant disease
Item
history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
boolean
C0751623 (UMLS CUI [1])
active infection
Item
active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
comorbidity
Item
any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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