ID

21468

Description

Dexamethasone and Supportive Care With or Without Whole-Brain Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer That Has Spread to the Brain and Cannot Be Removed By Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00403065

Link

https://clinicaltrials.gov/show/NCT00403065

Keywords

Versions (1)
  1. 4/23/17 4/23/17 -
Uploaded on

April 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00403065

English

Eligibility Lung Cancer NCT00403065

1 forms  
Criteria
Description

Criteria

histologically or cytologically confirmed primary non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205225
must have brain metastases confirmed by ct scan or mri
Description

Metastatic malignant neoplasm to brain X-Ray Computed Tomography | Metastatic malignant neoplasm to brain Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0024485
unresectable disease or surgery is deemed inappropriate
Description

Disease unresectable | Operative Surgical Procedures Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1548788
the benefit or lack of benefit of whole-brain radiotherapy (wbrt) cannot be clearly defined
Description

Whole brain radiotherapy Benefit | Whole brain radiotherapy Benefit Lack | Definition Clear Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1520143
UMLS CUI [1,2]
C0814225
UMLS CUI [2,1]
C1520143
UMLS CUI [2,2]
C0814225
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C1704788
UMLS CUI [3,2]
C2963144
UMLS CUI [3,3]
C0332197
any known certainty of the benefit or lack of benefit of wbrt is not allowed
Description

Whole brain radiotherapy Benefit | Whole brain radiotherapy Benefit Lack | Certainty Illicit

Data type

boolean

Alias
UMLS CUI [1,1]
C1520143
UMLS CUI [1,2]
C0814225
UMLS CUI [2,1]
C1520143
UMLS CUI [2,2]
C0814225
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C0205423
UMLS CUI [3,2]
C0332266
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
no prior or concurrent uncontrolled illness that could preclude study treatment or comparisons
Description

Disease Uncontrolled Excludes Protocol Compliance | Comorbidity Uncontrolled Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0525058
must be able to respond to weekly telephone assessment questions
Description

Telephone Assessment Answer questions Weekly

Data type

boolean

Alias
UMLS CUI [1,1]
C0039457
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0508431
UMLS CUI [1,4]
C0332174
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
more than 1 week since prior epidermal growth factor receptor inhibitors
Description

Epidermal growth factor receptor inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1443775
more than 1 month since prior chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
more than 1 month since prior surgery for brain metastases
Description

Operative Surgical Procedures Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0220650
no prior radiotherapy to the brain
Description

Radiotherapy to brain Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0948319
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Lung Cancer NCT00403065

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Small Cell Lung Carcinoma Primary
Item
histologically or cytologically confirmed primary non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain X-Ray Computed Tomography | Metastatic malignant neoplasm to brain Magnetic Resonance Imaging
Item
must have brain metastases confirmed by ct scan or mri
boolean
C0220650 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Disease unresectable | Operative Surgical Procedures Inappropriate
Item
unresectable disease or surgery is deemed inappropriate
boolean
C0012634 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Whole brain radiotherapy Benefit | Whole brain radiotherapy Benefit Lack | Definition Clear Absent
Item
the benefit or lack of benefit of whole-brain radiotherapy (wbrt) cannot be clearly defined
boolean
C1520143 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C1520143 (UMLS CUI [2,1])
C0814225 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C1704788 (UMLS CUI [3,1])
C2963144 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Whole brain radiotherapy Benefit | Whole brain radiotherapy Benefit Lack | Certainty Illicit
Item
any known certainty of the benefit or lack of benefit of wbrt is not allowed
boolean
C1520143 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C1520143 (UMLS CUI [2,1])
C0814225 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0205423 (UMLS CUI [3,1])
C0332266 (UMLS CUI [3,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Disease Uncontrolled Excludes Protocol Compliance | Comorbidity Uncontrolled Excludes Protocol Compliance
Item
no prior or concurrent uncontrolled illness that could preclude study treatment or comparisons
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Telephone Assessment Answer questions Weekly
Item
must be able to respond to weekly telephone assessment questions
boolean
C0039457 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0508431 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Epidermal growth factor receptor inhibitor
Item
more than 1 week since prior epidermal growth factor receptor inhibitors
boolean
C1443775 (UMLS CUI [1])
Chemotherapy
Item
more than 1 month since prior chemotherapy
boolean
C0392920 (UMLS CUI [1])
Operative Surgical Procedures Metastatic malignant neoplasm to brain
Item
more than 1 month since prior surgery for brain metastases
boolean
C0543467 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
Radiotherapy to brain Absent
Item
no prior radiotherapy to the brain
boolean
C0948319 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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