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ID

36556

Beskrivning

Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02460419

Länk

https://clinicaltrials.gov/show/NCT02460419

Nyckelord

  1. 2019-05-21 2019-05-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 maj 2019

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Nasopharyngeal Carcinoma NCT02460419

    Eligibility Nasopharyngeal Carcinoma NCT02460419

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    firstly diagnosed metastatic nasopharyngeal carcinoma patients
    Beskrivning

    Nasopharyngeal carcinoma metastatic

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2931822
    UMLS CUI [1,2]
    C1522484
    disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
    Beskrivning

    Disease Controlled | Status post Chemotherapy cycle Palliative Quantity | Taxol | Cisplatin | capecitabine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2911690
    UMLS CUI [2,1]
    C0231290
    UMLS CUI [2,2]
    C1302181
    UMLS CUI [2,3]
    C1285530
    UMLS CUI [2,4]
    C1265611
    UMLS CUI [3]
    C0678133
    UMLS CUI [4]
    C0008838
    UMLS CUI [5]
    C0671970
    eastern cooperative oncology group (ecog) 0-2
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectation at least 12 weeks
    Beskrivning

    Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    no systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
    Beskrivning

    Systemic Chemotherapy Absent | Exception Induction Chemotherapy | Exception Chemotherapy Concurrent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1883256
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C3179010
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0392920
    UMLS CUI [3,3]
    C0205420
    with at least one measurable lesion
    Beskrivning

    Measurable lesion Quantity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1265611
    enough blood test
    Beskrivning

    Hematologic Tests Sufficient

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0205410
    signed informed consent
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    sever heart disease
    Beskrivning

    Heart Disease Severe

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0205082
    hiv infection
    Beskrivning

    HIV Infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    sever infection
    Beskrivning

    Communicable Disease Severe

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205082
    brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
    Beskrivning

    Metastatic malignant neoplasm to brain | Exception Treatment Radical | Exception Stable status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C0439807
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0205360
    allogeneic organ transplantation
    Beskrivning

    Organ Transplantation Allogeneic

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0029216
    UMLS CUI [1,2]
    C1515895
    malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of ta,tis or t1, or any cured cancer for at least 3 years
    Beskrivning

    Malignant Neoplasms | Exception Nasopharyngeal carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Cured | Exception Carcinoma of bladder TNM clinical staging | Exception Malignant Neoplasms Cured

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C2931822
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0851140
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0007117
    UMLS CUI [4,3]
    C1880198
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0699885
    UMLS CUI [5,3]
    C3258246
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0006826
    UMLS CUI [6,3]
    C1880198
    pregnancy or breast feeding
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    difficulty in swallowing
    Beskrivning

    Deglutition Disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011168
    received other test drugs
    Beskrivning

    Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230

    Similar models

    Eligibility Nasopharyngeal Carcinoma NCT02460419

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Nasopharyngeal carcinoma metastatic
    Item
    firstly diagnosed metastatic nasopharyngeal carcinoma patients
    boolean
    C2931822 (UMLS CUI [1,1])
    C1522484 (UMLS CUI [1,2])
    Disease Controlled | Status post Chemotherapy cycle Palliative Quantity | Taxol | Cisplatin | capecitabine
    Item
    disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
    boolean
    C2911690 (UMLS CUI [1])
    C0231290 (UMLS CUI [2,1])
    C1302181 (UMLS CUI [2,2])
    C1285530 (UMLS CUI [2,3])
    C1265611 (UMLS CUI [2,4])
    C0678133 (UMLS CUI [3])
    C0008838 (UMLS CUI [4])
    C0671970 (UMLS CUI [5])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectation at least 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Systemic Chemotherapy Absent | Exception Induction Chemotherapy | Exception Chemotherapy Concurrent
    Item
    no systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
    boolean
    C1883256 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C3179010 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0392920 (UMLS CUI [3,2])
    C0205420 (UMLS CUI [3,3])
    Measurable lesion Quantity
    Item
    with at least one measurable lesion
    boolean
    C1513041 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Hematologic Tests Sufficient
    Item
    enough blood test
    boolean
    C0018941 (UMLS CUI [1,1])
    C0205410 (UMLS CUI [1,2])
    Informed Consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Heart Disease Severe
    Item
    sever heart disease
    boolean
    C0018799 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    HIV Infection
    Item
    hiv infection
    boolean
    C0019693 (UMLS CUI [1])
    Communicable Disease Severe
    Item
    sever infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Metastatic malignant neoplasm to brain | Exception Treatment Radical | Exception Stable status
    Item
    brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
    boolean
    C0220650 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C0439807 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0205360 (UMLS CUI [3,2])
    Organ Transplantation Allogeneic
    Item
    allogeneic organ transplantation
    boolean
    C0029216 (UMLS CUI [1,1])
    C1515895 (UMLS CUI [1,2])
    Malignant Neoplasms | Exception Nasopharyngeal carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Cured | Exception Carcinoma of bladder TNM clinical staging | Exception Malignant Neoplasms Cured
    Item
    malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of ta,tis or t1, or any cured cancer for at least 3 years
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C2931822 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0851140 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0007117 (UMLS CUI [4,2])
    C1880198 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0699885 (UMLS CUI [5,2])
    C3258246 (UMLS CUI [5,3])
    C1705847 (UMLS CUI [6,1])
    C0006826 (UMLS CUI [6,2])
    C1880198 (UMLS CUI [6,3])
    Pregnancy | Breast Feeding
    Item
    pregnancy or breast feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Deglutition Disorders
    Item
    difficulty in swallowing
    boolean
    C0011168 (UMLS CUI [1])
    Investigational New Drugs
    Item
    received other test drugs
    boolean
    C0013230 (UMLS CUI [1])

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