ID

41185

Description

Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00955695

Link

https://clinicaltrials.gov/show/NCT00955695

Keywords

Versions (1)
  1. 7/7/20 7/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 7, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT00955695

English

Eligibility Lung Cancer NCT00955695

1 forms  
Criteria
Description

Criteria

histologically confirmed non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
stage iiib or iv disease
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
Description

gefitinib | erlotinib hydrochloride

Data type

boolean

Alias
UMLS CUI [1]
C1122962
UMLS CUI [2]
C1533491
at least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
Description

Complete remission | Partial response | gefitinib | erlotinib hydrochloride

Data type

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C1521726
UMLS CUI [3]
C1122962
UMLS CUI [4]
C1533491
stable disease allowed provided 1 of the following criteria is met:
Description

Stable Disease | Criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1550543
egfr mutation (exon 19 or 21)
Description

EGFR Exon 19 Mutation | EGFR Exon 21 Mutation

Data type

boolean

Alias
UMLS CUI [1]
C4289656
UMLS CUI [2]
C4289654
having ≥ 2 of the following 3 factors:
Description

Factor Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C1265611
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
never smoked
Description

Never smoked tobacco

Data type

boolean

Alias
UMLS CUI [1]
C0425293
histologically confirmed adenocarcinoma of the lung
Description

Adenocarcinoma of lung

Data type

boolean

Alias
UMLS CUI [1]
C0152013
no evidence of brain metastases by ct scan or mri within the past 4 weeks
Description

Metastatic malignant neoplasm to brain Absent CT scan | Metastatic malignant neoplasm to brain Absent MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0024485
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
anc ≥ 1,500/mm^3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 150,000/mm^3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin < 1.5 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine < 1.5 times upper limit of normal
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Description

ID.19

Data type

boolean

received 1 or 2 prior systemic chemotherapy regimens
Description

Systemic Chemotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611
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Similar models

Eligibility Lung Cancer NCT00955695

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage iiib or iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
gefitinib | erlotinib hydrochloride
Item
must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
boolean
C1122962 (UMLS CUI [1])
C1533491 (UMLS CUI [2])
Complete remission | Partial response | gefitinib | erlotinib hydrochloride
Item
at least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
boolean
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C1122962 (UMLS CUI [3])
C1533491 (UMLS CUI [4])
Stable Disease | Criteria Quantity Fulfill
Item
stable disease allowed provided 1 of the following criteria is met:
boolean
C0677946 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
EGFR Exon 19 Mutation | EGFR Exon 21 Mutation
Item
egfr mutation (exon 19 or 21)
boolean
C4289656 (UMLS CUI [1])
C4289654 (UMLS CUI [2])
Factor Quantity
Item
having ≥ 2 of the following 3 factors:
boolean
C1521761 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Never smoked tobacco
Item
never smoked
boolean
C0425293 (UMLS CUI [1])
Adenocarcinoma of lung
Item
histologically confirmed adenocarcinoma of the lung
boolean
C0152013 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Absent CT scan | Metastatic malignant neoplasm to brain Absent MRI
Item
no evidence of brain metastases by ct scan or mri within the past 4 weeks
boolean
C0220650 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0220650 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
anc ≥ 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 150,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 times upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
ID.19
Item
see disease characteristics
boolean
Systemic Chemotherapy Quantity
Item
received 1 or 2 prior systemic chemotherapy regimens
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
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