ID

20442

Description

Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01196455

Link

https://clinicaltrials.gov/show/NCT01196455

Keywords

Versions (1)
  1. 2/22/17 2/22/17 -
Uploaded on

February 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01196455

English

Eligibility Breast Cancer NCT01196455

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically/cytologically confirmed breast cancer
Description

histologically/cytologically confirmed breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0332141
UMLS CUI [1,3]
C0679557
metastatic breast cancer, having at least one target lesion according to the recist criteria. bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral ct, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. in addition to the definitions pertaining to the target lesion(s) from the recist criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
Description

Metastatic Neoplasm; Breast Carcinoma; Target Lesion Identification | Secondary malignant neoplasm of bone | Leptomeningeal disease | Ascites | Pericardial effusion | Pleural effusion disorder | Inflammatory disorder of breast | Lymphangitic spread | Cystic Lesion | Conventional manometry | Tomography, Spiral Computed | prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C2986546
UMLS CUI [2]
C0153690
UMLS CUI [3]
C3160796
UMLS CUI [4]
C0003962
UMLS CUI [5]
C0031039
UMLS CUI [6]
C0032227
UMLS CUI [7]
C3495439
UMLS CUI [8]
C3697833
UMLS CUI [9]
C1511606
UMLS CUI [10]
C0441679
UMLS CUI [11]
C0860888
UMLS CUI [12]
C0279134
age > 18 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent obtained prior to initiation of any study-specific procedures or treatment
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
Description

prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0021083
UMLS CUI [3,1]
C2939420
UMLS CUI [3,2]
C0678222
prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
Description

prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0671970
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0002475
UMLS CUI [3]
C0600558
UMLS CUI [4]
C0677850
life expectancy < 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
not-ambulatory or with an ecog performance status > 1
Description

ECOG performance status | Ambulatory Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1550332
insufficient hematological, renal and hepatic functions:
Description

Renal function | Liver function | Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0221130
hemoglobin < 8.0 g/dl
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
absolute neutrophils count (anc) < 1.5 x 109/l
Description

anc

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 100 x 109/l
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine > 1.25 x n*
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin > 2.0 x n*
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
asat and/or alat > 2.5 x n* (in case of liver metastases > 5 x n*)
Description

asat, alat

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alkaline phosphatase > 2.5 x n* (in case of liver metastases > 5 x n*, in case of bone metastases > 10 x n*) *n = upper limit of standard range
Description

alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
severe renal impairment [creatinine clearance < 30 ml/min (calculated according to cockcroft and gault)]
Description

creatinine clearance, renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C0232804
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Similar models

Eligibility Breast Cancer NCT01196455

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
histologically/cytologically confirmed breast cancer
Item
histologically/cytologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0332141 (UMLS CUI [1,2])
C0679557 (UMLS CUI [1,3])
Metastatic Neoplasm; Breast Carcinoma; Target Lesion Identification | Secondary malignant neoplasm of bone | Leptomeningeal disease | Ascites | Pericardial effusion | Pleural effusion disorder | Inflammatory disorder of breast | Lymphangitic spread | Cystic Lesion | Conventional manometry | Tomography, Spiral Computed | prior radiation therapy
Item
metastatic breast cancer, having at least one target lesion according to the recist criteria. bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral ct, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. in addition to the definitions pertaining to the target lesion(s) from the recist criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
boolean
C2939420 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0153690 (UMLS CUI [2])
C3160796 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
C0031039 (UMLS CUI [5])
C0032227 (UMLS CUI [6])
C3495439 (UMLS CUI [7])
C3697833 (UMLS CUI [8])
C1511606 (UMLS CUI [9])
C0441679 (UMLS CUI [10])
C0860888 (UMLS CUI [11])
C0279134 (UMLS CUI [12])
age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
signed informed consent obtained prior to initiation of any study-specific procedures or treatment
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
Item
prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
boolean
C1514457 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C2939420 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
Item
prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
boolean
C1514463 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0002475 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
life expectancy
Item
life expectancy < 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status | Ambulatory Status
Item
not-ambulatory or with an ecog performance status > 1
boolean
C1520224 (UMLS CUI [1])
C1550332 (UMLS CUI [2])
Renal function | Liver function | Hematologic function
Item
insufficient hematological, renal and hepatic functions:
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
hemoglobin
Item
hemoglobin < 8.0 g/dl
boolean
C0019046 (UMLS CUI [1])
anc
Item
absolute neutrophils count (anc) < 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count < 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
creatinine
Item
serum creatinine > 1.25 x n*
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
total bilirubin > 2.0 x n*
boolean
C1278039 (UMLS CUI [1])
asat, alat
Item
asat and/or alat > 2.5 x n* (in case of liver metastases > 5 x n*)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
alkaline phosphatase
Item
alkaline phosphatase > 2.5 x n* (in case of liver metastases > 5 x n*, in case of bone metastases > 10 x n*) *n = upper limit of standard range
boolean
C0201850 (UMLS CUI [1])
creatinine clearance, renal function
Item
severe renal impairment [creatinine clearance < 30 ml/min (calculated according to cockcroft and gault)]
boolean
C0373595 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
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