ID

33354

Description

A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression; ODM derived from: https://clinicaltrials.gov/show/NCT01077726

Link

https://clinicaltrials.gov/show/NCT01077726

Keywords

  1. 12/6/18 12/6/18 -
  2. 12/6/18 12/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 6, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01077726

Eligibility Breast Cancer NCT01077726

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, >=18 years of age;
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
breast cancer;
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
cns progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
Description

CNS disorder Progressive | Status post Radiosurgery | Status post Whole brain radiation therapy | Status post Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0085203
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1520143
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0009429
at least one measurable lesion;
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
ecog performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic treatment of brain metastases;
Description

Systemic therapy Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0220650
prior disease progression while on xeloda treatment;
Description

Disease Progression | Xeloda

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0724419
previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
Description

Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
clinically significant cardiovascular disease.
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222

Similar models

Eligibility Breast Cancer NCT01077726

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, >=18 years of age;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
breast cancer;
boolean
C0678222 (UMLS CUI [1])
CNS disorder Progressive | Status post Radiosurgery | Status post Whole brain radiation therapy | Status post Combined Modality Therapy
Item
cns progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
boolean
C0007682 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0085203 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1520143 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0009429 (UMLS CUI [4,2])
Measurable lesion Quantity
Item
at least one measurable lesion;
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Metastatic malignant neoplasm to brain
Item
prior systemic treatment of brain metastases;
boolean
C1515119 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
Disease Progression | Xeloda
Item
prior disease progression while on xeloda treatment;
boolean
C0242656 (UMLS CUI [1])
C0724419 (UMLS CUI [2])
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Cardiovascular Disease
Item
clinically significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])

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