ID

22075

Description

Study of Enzastaurin Versus Placebo in the Treatment of Patients With Brain Metastases of Lung Cancer, After Whole Brain Radiation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00415363

Link

https://clinicaltrials.gov/show/NCT00415363

Keywords

  1. 5/18/17 5/18/17 -
Uploaded on

May 18, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Non Small Cell Lung Cancer NCT00415363

Eligibility Non Small Cell Lung Cancer NCT00415363

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
having radiologically proven brain metastases of lung cancer
Description

Lung Carcinoma Metastatic in the Brain

Data type

boolean

Alias
UMLS CUI [1]
C1334441
having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
Description

Whole brain radiotherapy | Gray unit of radiation dose Quantity Week Quantity | enzastaurin

Data type

boolean

Alias
UMLS CUI [1]
C1520143
UMLS CUI [2,1]
C0556636
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439230
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C1327830
no other previous radiotherapy to the brain except for radiosurgery at one occasion
Description

Radiotherapy to brain | Radiosurgery Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0948319
UMLS CUI [2,1]
C0085203
UMLS CUI [2,2]
C1265611
adequate organ function as measured by appropriate laboratory tests.
Description

Organ function Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0022885
age 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
Description

Able to swallow Tablets | Condition Interferes with Oral medication administration | Vomiting | Partial bowel obstruction

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0039225
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0001563
UMLS CUI [3]
C0042963
UMLS CUI [4]
C1328480
inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
Description

Antiepileptic Agents Unable to discontinue | Carbamazepine | Phenobarbital | Phenytoin

Data type

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C1548265
UMLS CUI [2]
C0006949
UMLS CUI [3]
C0031412
UMLS CUI [4]
C0031507
concurrent administration of warfarin
Description

Warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
hemophilia
Description

Hemophilia

Data type

boolean

Alias
UMLS CUI [1]
C0684275
having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.
Description

Cancer treatment Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373

Similar models

Eligibility Non Small Cell Lung Cancer NCT00415363

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lung Carcinoma Metastatic in the Brain
Item
having radiologically proven brain metastases of lung cancer
boolean
C1334441 (UMLS CUI [1])
Whole brain radiotherapy | Gray unit of radiation dose Quantity Week Quantity | enzastaurin
Item
having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
boolean
C1520143 (UMLS CUI [1])
C0556636 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439230 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1327830 (UMLS CUI [3])
Radiotherapy to brain | Radiosurgery Quantity
Item
no other previous radiotherapy to the brain except for radiosurgery at one occasion
boolean
C0948319 (UMLS CUI [1])
C0085203 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Organ function Laboratory Procedures
Item
adequate organ function as measured by appropriate laboratory tests.
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Able to swallow Tablets | Condition Interferes with Oral medication administration | Vomiting | Partial bowel obstruction
Item
inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
boolean
C2712086 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0001563 (UMLS CUI [2,3])
C0042963 (UMLS CUI [3])
C1328480 (UMLS CUI [4])
Antiepileptic Agents Unable to discontinue | Carbamazepine | Phenobarbital | Phenytoin
Item
inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
boolean
C0003299 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0006949 (UMLS CUI [2])
C0031412 (UMLS CUI [3])
C0031507 (UMLS CUI [4])
Warfarin
Item
concurrent administration of warfarin
boolean
C0043031 (UMLS CUI [1])
Hemophilia
Item
hemophilia
boolean
C0684275 (UMLS CUI [1])
Cancer treatment Systemic
Item
having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])

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