ID

20417

Description

Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00875355

Link

https://clinicaltrials.gov/show/NCT00875355

Keywords

  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 NCT00875355

Eligibility Breast Cancer NCT00875355

Criteria
Description

Criteria

diagnosis of breast cancer
Description

breast carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
unresectable disease or patient refused surgery
Description

unresectable disease or patient refused surgery

Data type

boolean

Alias
UMLS CUI [1]
C1336869
UMLS CUI [2]
C0749192
must have brain metastases
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
patient characteristics:
Description

characteristics

Data type

boolean

Alias
UMLS CUI [1]
C1521970
who performance status 0-2
Description

who performance status

Data type

boolean

Alias
UMLS CUI [1]
C1298651
anc ≥ 1,500/mm³
Description

anc

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100,000/mm³
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
liver transaminases ≤ 1.5 times upper limit of normal (uln)
Description

liver transaminases

Data type

boolean

Alias
UMLS CUI [1]
C1856363
creatinine < 1.5 times uln
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
not pregnant or nursing
Description

not pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0085537
fertile patients must use effective contraception
Description

Contraceptive methods; Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3831118
no carcinomatous meningitis
Description

carcinomatous meningitis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
no history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
Description

History of neoplastic disease | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
no other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment
Description

comorbidity limited protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
no contraindications to treatment with temozolomide
Description

no contraindications to treatment with temozolomide

Data type

boolean

Alias
UMLS CUI [1,1]
C0076080
UMLS CUI [1,2]
C1301624
no psychological, familial, social, or geographic situations that preclude clinical follow up
Description

limited protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0439801
UMLS CUI [1,2]
C0525058
no patient deprived of liberty or under guardianship
Description

guardianship

Data type

boolean

Alias
UMLS CUI [1]
C0870627
prior concurrent therapy:
Description

prior concurrent therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0009429
no prior brain radiotherapy
Description

prior brain radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0948319
UMLS CUI [1,2]
C1514463
at least 10 days since prior chemotherapy
Description

prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457

Similar models

Eligibility Breast Cancer NCT00875355

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
breast carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
unresectable disease or patient refused surgery
Item
unresectable disease or patient refused surgery
boolean
C1336869 (UMLS CUI [1])
C0749192 (UMLS CUI [2])
brain metastases
Item
must have brain metastases
boolean
C0220650 (UMLS CUI [1])
characteristics
Item
patient characteristics:
boolean
C1521970 (UMLS CUI [1])
who performance status
Item
who performance status 0-2
boolean
C1298651 (UMLS CUI [1])
anc
Item
anc ≥ 1,500/mm³
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count ≥ 100,000/mm³
boolean
C0005821 (UMLS CUI [1])
liver transaminases
Item
liver transaminases ≤ 1.5 times upper limit of normal (uln)
boolean
C1856363 (UMLS CUI [1])
creatinine
Item
creatinine < 1.5 times uln
boolean
C0201976 (UMLS CUI [1])
not pregnant or nursing
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0085537 (UMLS CUI [2])
Contraceptive methods; Childbearing Potential
Item
fertile patients must use effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
carcinomatous meningitis
Item
no carcinomatous meningitis
boolean
C0220654 (UMLS CUI [1])
History of neoplastic disease | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
no history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
comorbidity limited protocol compliance
Item
no other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
no contraindications to treatment with temozolomide
Item
no contraindications to treatment with temozolomide
boolean
C0076080 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
limited protocol compliance
Item
no psychological, familial, social, or geographic situations that preclude clinical follow up
boolean
C0439801 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
guardianship
Item
no patient deprived of liberty or under guardianship
boolean
C0870627 (UMLS CUI [1])
prior concurrent therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
prior brain radiotherapy
Item
no prior brain radiotherapy
boolean
C0948319 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
prior chemotherapy
Item
at least 10 days since prior chemotherapy
boolean
C1514457 (UMLS CUI [1])

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