ID

41188

Description

Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01514877

Link

https://clinicaltrials.gov/show/NCT01514877

Keywords

Versions (1)
  1. 7/8/20 7/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 8, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT01514877

English

Eligibility Lung Cancer NCT01514877

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
cytologic or histological diagnosis of non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with egfr mutation status who have not been treated
Description

Disease Progression | Status post Systemic Chemotherapy | Combined Modality Therapy | platinum | Patients EGFR mutation Untreated

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1883256
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0032207
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C3266992
UMLS CUI [5,3]
C0332155
patients are diagnosed with multiple brain metastases for the first time in 4 weeks
Description

Metastatic malignant neoplasm to brain multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0439064
diagnosis of brain metastases is made based on magnetic resonance imaging (mri).
Description

Metastatic malignant neoplasm to brain MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0024485
doctors consider the patient will benefit from wbrt
Description

Whole brain radiation therapy Benefit considered

Data type

boolean

Alias
UMLS CUI [1,1]
C1520143
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0750591
no prior brain radiotherapy
Description

Radiotherapy to brain Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0948319
UMLS CUI [1,2]
C0332197
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age:18-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
neutrophil count ≥1.5×10 to the 9th power/l and platelets≥100×10 to the 9th power/l. hemoglobin ≥90 g/l
Description

Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (uln) alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln (or less than or equal to 5 times uln in case of known liver involvement)
Description

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5,1]
C0023884
UMLS CUI [5,2]
C1314939
renal: serum creatinine less than or equal to 1.5 times upper limit of normal (uln)
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
patients with measurable brain metastases according to the response evaluation criteria in solid tumors (recist) criteria
Description

Metastatic malignant neoplasm to brain Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1513040
patients must sign an informed consent indicating that they are aware of the investigational nature of the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior brain radiation therapy
Description

Radiotherapy to brain Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0948319
UMLS CUI [1,2]
C0205156
solitary brain metastasis according to magnetic resonance imaging (mri)
Description

Metastatic malignant neoplasm to brain Solitary MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0024485
mort than 3 extracranial organs have metastatic lesions
Description

Metastatic Lesion Organ Extracranial Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0580586
UMLS CUI [1,4]
C1265611
prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
Description

Prior Invasive Malignancy | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C4743663
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
pregnant or breast feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Lung Cancer NCT01514877

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
cytologic or histological diagnosis of non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Disease Progression | Status post Systemic Chemotherapy | Combined Modality Therapy | platinum | Patients EGFR mutation Untreated
Item
patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with egfr mutation status who have not been treated
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1883256 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
C0032207 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C3266992 (UMLS CUI [5,2])
C0332155 (UMLS CUI [5,3])
Metastatic malignant neoplasm to brain multiple
Item
patients are diagnosed with multiple brain metastases for the first time in 4 weeks
boolean
C0220650 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain MRI
Item
diagnosis of brain metastases is made based on magnetic resonance imaging (mri).
boolean
C0220650 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Whole brain radiation therapy Benefit considered
Item
doctors consider the patient will benefit from wbrt
boolean
C1520143 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0750591 (UMLS CUI [1,3])
Radiotherapy to brain Absent
Item
no prior brain radiotherapy
boolean
C0948319 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age:18-75 years
boolean
C0001779 (UMLS CUI [1])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
neutrophil count ≥1.5×10 to the 9th power/l and platelets≥100×10 to the 9th power/l. hemoglobin ≥90 g/l
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement
Item
hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (uln) alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln (or less than or equal to 5 times uln in case of known liver involvement)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0023884 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
Renal function | Creatinine measurement, serum
Item
renal: serum creatinine less than or equal to 1.5 times upper limit of normal (uln)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Measurable
Item
patients with measurable brain metastases according to the response evaluation criteria in solid tumors (recist) criteria
boolean
C0220650 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Informed Consent
Item
patients must sign an informed consent indicating that they are aware of the investigational nature of the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to brain Previous
Item
prior brain radiation therapy
boolean
C0948319 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Solitary MRI
Item
solitary brain metastasis according to magnetic resonance imaging (mri)
boolean
C0220650 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Metastatic Lesion Organ Extracranial Quantity
Item
mort than 3 extracranial organs have metastatic lesions
boolean
C1513183 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0580586 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Prior Invasive Malignancy | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
boolean
C4743663 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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