ID

13208

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00831545

Nyckelord

Versioner (1)
  1. 2016-01-24 2016-01-24 -
Uppladdad den

24 januari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastases of Central Nervous System NCT00831545

Engelsk

Eligibility Metastases of Central Nervous System NCT00831545

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

melanoma, non-small cell lung cancer and breast cancer

Datatyp

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;
Beskrivning

brain metastases

Datatyp

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.
Beskrivning

magnetic resonance imaging

Datatyp

boolean

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

measurable disease

Datatyp

boolean

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

age

Datatyp

boolean

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

ecog

Datatyp

boolean

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

leukocytes, platelets

Datatyp

boolean

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

bilirubin

Datatyp

boolean

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

transaminases

Datatyp

boolean

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

creatinine/-clearance

Datatyp

boolean

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

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

diabetes

Datatyp

boolean

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

whole brain irradiation

Datatyp

boolean

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

neurosurgery, radiotherapy

Datatyp

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.
Beskrivning

malignancies

Datatyp

boolean

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

pregnant or nursing

Datatyp

boolean

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

intravenous antibiotics

Datatyp

boolean

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

vomiting

Datatyp

boolean

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

anticonvulsants

Datatyp

boolean

Alias
UMLS CUI [1]
C0003286
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Similar models

Eligibility Metastases of Central Nervous System NCT00831545

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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