ID

21473

Description

Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00390806

Link

https://clinicaltrials.gov/show/NCT00390806

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, Non-Small Cell NCT00390806

English

Eligibility Lung Cancer, Non-Small Cell NCT00390806

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (nsclc)
Description

Measurable Disease Malignant Quantity Brain | Non-Small Cell Lung Carcinoma Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205282
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0006104
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205225
must have received previous chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
must be 18 years of age of greater
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
must be easter cooperative oncology group (ecog) performance status 0, 1, 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
at least 2 weeks must have elapsed since any surgery
Description

Operative Surgical Procedures Elapsed Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826303
at least 4 weeks must have elapsed since any radiation to a non-cns site
Description

Therapeutic radiology procedure Site outside Central Nervous System | Elapsed Time

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205101
UMLS CUI [1,4]
C3714787
UMLS CUI [2]
C2826303
must have adequate bone marrow, renal, and live capacities
Description

Bone Marrow function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
women must be of non-childbearing potential or practice adequate birth control
Description

Childbearing Potential Absent | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
males must practice adequate methods of birth control
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
must sign written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous whole brain radiation therapy
Description

Whole brain radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1520143
prior treatment with topotecan
Description

Topotecan

Data type

boolean

Alias
UMLS CUI [1]
C0146224
investigational agent within 30 days or 5 half-live
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
concomitant therapy with inhibitors of breast cancer resistance protein (bcrp) or p-glycoprotein such as erlotinib or gefitinib
Description

Breast Cancer Resistance Protein Inhibitors | P-Glycoprotein | erlotinib | gefitinib

Data type

boolean

Alias
UMLS CUI [1]
C3819035
UMLS CUI [2]
C0242643
UMLS CUI [3]
C1135135
UMLS CUI [4]
C1122962
primary or secondary immunodeficiencies
Description

Primary immunodeficiency | Secondary immunodeficiency

Data type

boolean

Alias
UMLS CUI [1]
C0398686
UMLS CUI [2]
C0398795
gastrointestinal conditions that affect gi absorption or motility
Description

Gastrointestinal Disease Affecting Gastrointestinal Absorption | Gastrointestinal Disease Affecting Gastrointestinal Motility

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3714657
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0017184
uncontrolled emesis
Description

Uncontrolled Vomiting

Data type

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C0042963
brain metastasis at time of initial diagnosis of nsclc
Description

Metastatic malignant neoplasm to brain | Initial diagnosis Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C4071762
UMLS CUI [2,2]
C0007131
history of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
Description

Malignant Neoplasms | Carcinoma in situ of uterine cervix | Skin carcinoma | Prostate carcinoma low grade

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
UMLS CUI [3]
C0699893
UMLS CUI [4,1]
C0600139
UMLS CUI [4,2]
C1282907
pregnant or intending to become pregnant or intending to father a baby
Description

Pregnancy | Pregnancy, Planned | Reproduction intended

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0035150
UMLS CUI [3,2]
C1283828
any severe concurrent medical condition that could affect compliance.
Description

Comorbidity Affecting Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1321605
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Similar models

Eligibility Lung Cancer, Non-Small Cell NCT00390806

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Measurable Disease Malignant Quantity Brain | Non-Small Cell Lung Carcinoma Primary
Item
at least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (nsclc)
boolean
C1513041 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0006104 (UMLS CUI [1,4])
C0007131 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Chemotherapy
Item
must have received previous chemotherapy
boolean
C0392920 (UMLS CUI [1])
Age
Item
must be 18 years of age of greater
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
must be easter cooperative oncology group (ecog) performance status 0, 1, 2
boolean
C1520224 (UMLS CUI [1])
Operative Surgical Procedures Elapsed Time
Item
at least 2 weeks must have elapsed since any surgery
boolean
C0543467 (UMLS CUI [1,1])
C2826303 (UMLS CUI [1,2])
Therapeutic radiology procedure Site outside Central Nervous System | Elapsed Time
Item
at least 4 weeks must have elapsed since any radiation to a non-cns site
boolean
C1522449 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205101 (UMLS CUI [1,3])
C3714787 (UMLS CUI [1,4])
C2826303 (UMLS CUI [2])
Bone Marrow function | Renal function | Liver function
Item
must have adequate bone marrow, renal, and live capacities
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Childbearing Potential Absent | Childbearing Potential Contraceptive methods
Item
women must be of non-childbearing potential or practice adequate birth control
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Gender Contraceptive methods
Item
males must practice adequate methods of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
must sign written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Whole brain radiotherapy
Item
previous whole brain radiation therapy
boolean
C1520143 (UMLS CUI [1])
Topotecan
Item
prior treatment with topotecan
boolean
C0146224 (UMLS CUI [1])
Investigational New Drugs
Item
investigational agent within 30 days or 5 half-live
boolean
C0013230 (UMLS CUI [1])
Breast Cancer Resistance Protein Inhibitors | P-Glycoprotein | erlotinib | gefitinib
Item
concomitant therapy with inhibitors of breast cancer resistance protein (bcrp) or p-glycoprotein such as erlotinib or gefitinib
boolean
C3819035 (UMLS CUI [1])
C0242643 (UMLS CUI [2])
C1135135 (UMLS CUI [3])
C1122962 (UMLS CUI [4])
Primary immunodeficiency | Secondary immunodeficiency
Item
primary or secondary immunodeficiencies
boolean
C0398686 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
Gastrointestinal Disease Affecting Gastrointestinal Absorption | Gastrointestinal Disease Affecting Gastrointestinal Motility
Item
gastrointestinal conditions that affect gi absorption or motility
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3714657 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0017184 (UMLS CUI [2,3])
Uncontrolled Vomiting
Item
uncontrolled emesis
boolean
C0205318 (UMLS CUI [1,1])
C0042963 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Initial diagnosis Non-Small Cell Lung Carcinoma
Item
brain metastasis at time of initial diagnosis of nsclc
boolean
C0220650 (UMLS CUI [1])
C4071762 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Malignant Neoplasms | Carcinoma in situ of uterine cervix | Skin carcinoma | Prostate carcinoma low grade
Item
history of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
C0600139 (UMLS CUI [4,1])
C1282907 (UMLS CUI [4,2])
Pregnancy | Pregnancy, Planned | Reproduction intended
Item
pregnant or intending to become pregnant or intending to father a baby
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0035150 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Comorbidity Affecting Compliance behavior
Item
any severe concurrent medical condition that could affect compliance.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
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