ID

13208

Description

Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064); ODM derived from: https://clinicaltrials.gov/show/NCT00831545

Link

https://clinicaltrials.gov/show/NCT00831545

Keywords

Versions (1)
  1. 1/24/16 1/24/16 -
Uploaded on

January 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastases of Central Nervous System NCT00831545

English

Eligibility Metastases of Central Nervous System NCT00831545

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
Description

melanoma, non-small cell lung cancer and breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0025202
UMLS CUI [2]
C0007131
UMLS CUI [3]
C0678222
brain metastases >=1 cm presenting or in progression following >=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in t1 and t2 before and after gadolinium enhancement.
Description

magnetic resonance imaging

Data type

boolean

Alias
UMLS CUI [1]
C0024485
presence of al least one bidimensionally measurable and not previously irradiated metastasis.
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
age <=70 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status 0-2 (ecog-who scale).
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
blood leukocytes >=3.5 x 10^9/l and platelets >=100 x 10^9/l.
Description

leukocytes, platelets

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
bilirubin <=25 m/l.
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
seric transaminases <=2 x upper limit of normal values.
Description

transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
creatinine <=150 m/l, creatinine clearance >=60 ml/min.
Description

creatinine/-clearance

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
signed written informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
Description

diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
previous whole brain irradiation.
Description

whole brain irradiation

Data type

boolean

Alias
UMLS CUI [1]
C1520143
brain metastases eligible to neurosurgery or stereotactic radiation therapy.
Description

neurosurgery, radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0524850
UMLS CUI [2]
C1522449
previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
pregnant or nursing women.
Description

pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute infection requiring intravenous antibiotics.
Description

intravenous antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0021441
severe vomiting or medical condition which could interfere with oral medication intake.
Description

vomiting

Data type

boolean

Alias
UMLS CUI [1]
C0042963
anticonvulsant chronic therapy.
Description

anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0003286
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Similar models

Eligibility Metastases of Central Nervous System NCT00831545

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
melanoma, non-small cell lung cancer and breast cancer
Item
cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
boolean
C0025202 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C0678222 (UMLS CUI [3])
brain metastases
Item
brain metastases >=1 cm presenting or in progression following >=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
boolean
C0220650 (UMLS CUI [1])
magnetic resonance imaging
Item
magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in t1 and t2 before and after gadolinium enhancement.
boolean
C0024485 (UMLS CUI [1])
measurable disease
Item
presence of al least one bidimensionally measurable and not previously irradiated metastasis.
boolean
C1513041 (UMLS CUI [1])
age
Item
age <=70 years.
boolean
C0001779 (UMLS CUI [1])
ecog
Item
performance status 0-2 (ecog-who scale).
boolean
C1520224 (UMLS CUI [1])
leukocytes, platelets
Item
blood leukocytes >=3.5 x 10^9/l and platelets >=100 x 10^9/l.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
bilirubin
Item
bilirubin <=25 m/l.
boolean
C1278039 (UMLS CUI [1])
transaminases
Item
seric transaminases <=2 x upper limit of normal values.
boolean
C0002594 (UMLS CUI [1])
creatinine/-clearance
Item
creatinine <=150 m/l, creatinine clearance >=60 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
informed consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
diabetes
Item
diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
boolean
C0011849 (UMLS CUI [1])
whole brain irradiation
Item
previous whole brain irradiation.
boolean
C1520143 (UMLS CUI [1])
neurosurgery, radiotherapy
Item
brain metastases eligible to neurosurgery or stereotactic radiation therapy.
boolean
C0524850 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
malignancies
Item
previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
pregnant or nursing
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
intravenous antibiotics
Item
acute infection requiring intravenous antibiotics.
boolean
C0003232 (UMLS CUI [1,1])
C0021441 (UMLS CUI [1,2])
vomiting
Item
severe vomiting or medical condition which could interfere with oral medication intake.
boolean
C0042963 (UMLS CUI [1])
anticonvulsants
Item
anticonvulsant chronic therapy.
boolean
C0003286 (UMLS CUI [1])
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