ID

26092

Description

Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00639366

Link

https://clinicaltrials.gov/show/NCT00639366

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00639366

English

Eligibility Breast Cancer NCT00639366

1 forms  
Criteria
Description

Criteria

histologically proven breast carcinoma
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
metastatic or locally advanced disease
Description

Neoplasm Metastasis | Advanced disease Locally

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0679246
UMLS CUI [2,2]
C1517927
must demonstrate her2 3+ positivity on ihc or 2+ over-expression and fish test demonstrating c-erb2 gene amplification
Description

HER2/Neu Positive Immunohistochemistry | erbB-2 Receptor Protein Overexpression | HER2 gene amplification FISH

Data type

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1514559
UMLS CUI [3,1]
C1512127
UMLS CUI [3,2]
C0162789
no known or suspected brain metastases or cns disease, as defined by the presence of any of the following key symptoms:
Description

Metastatic malignant neoplasm to brain Absent | Metastatic malignant neoplasm to brain Suspected Absent | CNS disorder Absent | Symptoms Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0007682
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C1542147
headache
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
nausea and/or vomiting
Description

Nausea | Vomiting

Data type

boolean

Alias
UMLS CUI [1]
C0027497
UMLS CUI [2]
C0042963
clinical signs of raised intracranial pressure
Description

Sign or Symptom Raised intracranial pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0437215
seizures
Description

Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
focal symptoms
Description

Symptoms Focal

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205234
cognitive dysfunction
Description

Impaired cognition

Data type

boolean

Alias
UMLS CUI [1]
C0338656
affective disorder
Description

Mood Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0525045
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
postmenopausal status not specified
Description

Postmenopausal state Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0205370
ecog performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must a-priori be suitable for trastuzumab (herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function
Description

Patients Appropriate Chemotherapy | Trastuzumab | Herceptin | Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0392920
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0338204
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0232804
no prior history of cerebrovascular disease or neurological disorder including seizures
Description

Cerebrovascular Disorders Absent | Nervous system disorder Absent | Seizures Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0036572
UMLS CUI [3,2]
C0332197
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior cranial radiotherapy
Description

Absence Therapeutic radiology procedure cranial

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0037303
no prior neurosurgery
Description

Neurosurgical Procedures Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Breast Cancer NCT00639366

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
histologically proven breast carcinoma
boolean
C0678222 (UMLS CUI [1])
Neoplasm Metastasis | Advanced disease Locally
Item
metastatic or locally advanced disease
boolean
C0027627 (UMLS CUI [1])
C0679246 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
HER2/Neu Positive Immunohistochemistry | erbB-2 Receptor Protein Overexpression | HER2 gene amplification FISH
Item
must demonstrate her2 3+ positivity on ihc or 2+ over-expression and fish test demonstrating c-erb2 gene amplification
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0069515 (UMLS CUI [2,1])
C1514559 (UMLS CUI [2,2])
C1512127 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Absent | Metastatic malignant neoplasm to brain Suspected Absent | CNS disorder Absent | Symptoms Main
Item
no known or suspected brain metastases or cns disease, as defined by the presence of any of the following key symptoms:
boolean
C0220650 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0007682 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C1542147 (UMLS CUI [4,2])
Headache
Item
headache
boolean
C0018681 (UMLS CUI [1])
Nausea | Vomiting
Item
nausea and/or vomiting
boolean
C0027497 (UMLS CUI [1])
C0042963 (UMLS CUI [2])
Sign or Symptom Raised intracranial pressure
Item
clinical signs of raised intracranial pressure
boolean
C3540840 (UMLS CUI [1,1])
C0437215 (UMLS CUI [1,2])
Seizures
Item
seizures
boolean
C0036572 (UMLS CUI [1])
Symptoms Focal
Item
focal symptoms
boolean
C1457887 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Impaired cognition
Item
cognitive dysfunction
boolean
C0338656 (UMLS CUI [1])
Mood Disorders
Item
affective disorder
boolean
C0525045 (UMLS CUI [1])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Postmenopausal state Unspecified
Item
postmenopausal status not specified
boolean
C0232970 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Patients Appropriate Chemotherapy | Trastuzumab | Herceptin | Bone Marrow function | Liver function | Renal function
Item
patients must a-priori be suitable for trastuzumab (herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C0338204 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C0232741 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
Cerebrovascular Disorders Absent | Nervous system disorder Absent | Seizures Absent
Item
no prior history of cerebrovascular disease or neurological disorder including seizures
boolean
C0007820 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Absence Therapeutic radiology procedure cranial
Item
no prior cranial radiotherapy
boolean
C0332197 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0037303 (UMLS CUI [1,3])
Neurosurgical Procedures Absent
Item
no prior neurosurgery
boolean
C0524850 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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