ID

30594

Description

Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00706069

Link

https://clinicaltrials.gov/show/NCT00706069

Keywords

Versions (1)
  1. 6/17/18 6/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00706069

English

Eligibility Metastatic Breast Cancer NCT00706069

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
age 18-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bidimensionally measurable or evaluable disease
Description

Measurable Disease 2-Dimensional | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2]
C1516986
performance status (ps) 0-2 (ecog)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment
Description

Females & males of reproductive potential Contraceptive methods | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier | Spermatocidal Agents | Sexual sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0036899
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0037862
UMLS CUI [7]
C0038288
adequate liver (serum bilirubin <1.5 times the upper normal limit, ast and alt <2.5 times the unl in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and adequate bone marrow function(neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l)
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C0494165
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0494165
UMLS CUI [6,2]
C0150312
UMLS CUI [7]
C0232804
UMLS CUI [8]
C0201976
UMLS CUI [9,1]
C0005953
UMLS CUI [9,2]
C0031843
UMLS CUI [10]
C0200633
UMLS CUI [11]
C0032181
at least three weeks from completion of irradiation
Description

Therapeutic radiology procedure Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
life expectancy ≥ 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients able to take oral medication
Description

Able to swallow Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Description

Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
malnutrition (loss of ≥ 20% of the original body weight)
Description

Malnutrition | Weight decreased Percentage Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0162429
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0005910
psychiatric illness or social situation that would preclude study compliance
Description

Mental disorders Protocol Compliance Excluded | Social situation Protocol Compliance Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0332196
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Metastatic Breast Cancer NCT00706069

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
histologically confirmed metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Age
Item
age 18-75 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease 2-Dimensional | Evaluable Disease
Item
bidimensionally measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
performance status (ps) 0-2 (ecog)
boolean
C1520224 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier | Spermatocidal Agents | Sexual sterilization
Item
patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0036899 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0037862 (UMLS CUI [6])
C0038288 (UMLS CUI [7])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Neutrophil count | Platelet Count measurement
Item
adequate liver (serum bilirubin <1.5 times the upper normal limit, ast and alt <2.5 times the unl in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and adequate bone marrow function(neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0494165 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0494165 (UMLS CUI [6,1])
C0150312 (UMLS CUI [6,2])
C0232804 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C0031843 (UMLS CUI [9,2])
C0200633 (UMLS CUI [10])
C0032181 (UMLS CUI [11])
Therapeutic radiology procedure Completed
Item
at least three weeks from completion of irradiation
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
Able to swallow Oral medication
Item
patients able to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Malnutrition | Weight decreased Percentage Body Weight
Item
malnutrition (loss of ≥ 20% of the original body weight)
boolean
C0162429 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
Mental disorders Protocol Compliance Excluded | Social situation Protocol Compliance Excluded
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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