0 Evaluaciones
ID

13208

Descripción

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

Palabras clave

Versiones (1)
  1. 2016-01-24 2016-01-24 -
Subido en

24 januari 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Eligibility Metastases of Central Nervous System NCT00831545

    Inglés

    Eligibility Metastases of Central Nervous System NCT00831545

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

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

    melanoma, non-small cell lung cancer and breast cancer

    Tipo de datos

    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;
    Descripción

    brain metastases

    Tipo de datos

    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.
    Descripción

    magnetic resonance imaging

    Tipo de datos

    boolean

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

    measurable disease

    Tipo de datos

    boolean

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

    age

    Tipo de datos

    boolean

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

    ecog

    Tipo de datos

    boolean

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

    leukocytes, platelets

    Tipo de datos

    boolean

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

    bilirubin

    Tipo de datos

    boolean

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

    transaminases

    Tipo de datos

    boolean

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

    creatinine/-clearance

    Tipo de datos

    boolean

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

    informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

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

    diabetes

    Tipo de datos

    boolean

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

    whole brain irradiation

    Tipo de datos

    boolean

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

    neurosurgery, radiotherapy

    Tipo de datos

    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.
    Descripción

    malignancies

    Tipo de datos

    boolean

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

    pregnant or nursing

    Tipo de datos

    boolean

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

    intravenous antibiotics

    Tipo de datos

    boolean

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

    vomiting

    Tipo de datos

    boolean

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

    anticonvulsants

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0003286
    Volver a la parte superior de la página

    Similar models

    Eligibility Metastases of Central Nervous System NCT00831545

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial