0 Bedömningar
ID

23172

Beskrivning

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar; ODM derived from: https://clinicaltrials.gov/show/NCT00476476

Länk

https://clinicaltrials.gov/show/NCT00476476

Nyckelord

Versioner (1)
  1. 2017-06-26 2017-06-26 -
Uppladdad den

26 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Squamous Cell Carcinoma NCT00476476

    Engelsk

    Eligibility Squamous Cell Carcinoma NCT00476476

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically confirmed measurable squamous cell carcinoma of the vulvar with an assessable lesion on the vulva or measurable metastatic disease. tumors may be primary or recurrent. patients must have plans for surgery or definitive treatment with chemotherapy +/-radiation unless they have measurable metastatic disease.
    Beskrivning

    Squamous cell carcinoma of vulva Measurable | Lesion of vulva Assessment | Neoplasm Metastasis Measurable | Primary tumor | Recurrent tumor | Operative Surgical Procedures Planned | Chemotherapy | Therapeutic radiology procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0280856
    UMLS CUI [1,2]
    C1513040
    UMLS CUI [2,1]
    C0221784
    UMLS CUI [2,2]
    C1516048
    UMLS CUI [3,1]
    C0027627
    UMLS CUI [3,2]
    C1513040
    UMLS CUI [4]
    C0677930
    UMLS CUI [5]
    C0521158
    UMLS CUI [6,1]
    C0543467
    UMLS CUI [6,2]
    C1301732
    UMLS CUI [7]
    C0392920
    UMLS CUI [8]
    C1522449
    18 years of age or older
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    no concurrent chemotherapy or radiotherapy
    Beskrivning

    Chemotherapy Absent | Therapeutic radiology procedure Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0332197
    no previous chemotherapy or radiotherapy within the preceding 1 month
    Beskrivning

    Prior Chemotherapy Absent | Prior radiation therapy Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0279134
    UMLS CUI [2,2]
    C0332197
    ecog performance status of 0-1
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    known hypersensitivity reaction to erlotinib
    Beskrivning

    Hypersensitivity erlotinib

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1135135
    other coexisting malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma
    Beskrivning

    Malignant Neoplasms | Basal cell carcinoma Excluded

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C0007117
    UMLS CUI [2,2]
    C2828389
    treatment with a non-fda approved or investigational drug within 30 days
    Beskrivning

    Drugs, Non-Prescription | Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013231
    UMLS CUI [2]
    C0013230
    persistent toxicities (grade 2 or above) from previous treatment, expect alopecia or lymphedema
    Beskrivning

    Prior Therapy | Toxicity persistent CTCAE Grades | Alopecia | Lymphedema

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1514463
    UMLS CUI [2,1]
    C0600688
    UMLS CUI [2,2]
    C0205322
    UMLS CUI [2,3]
    C1516728
    UMLS CUI [3]
    C0002170
    UMLS CUI [4]
    C0024236
    serum creatinine level greater than ctc grade 2
    Beskrivning

    Creatinine measurement, serum | CTCAE Grades

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C1516728
    pregnancy or breast feeding
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    severe or uncontrolled systemic disease
    Beskrivning

    Systemic disease Severe | Systemic disease Uncontrolled

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0442893
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0442893
    UMLS CUI [2,2]
    C0205318
    significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
    Beskrivning

    Disease Study Subject Participation Status At risk | Laboratory test finding Study Subject Participation Status At risk

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [2,1]
    C0587081
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C1444641
    Tillbaka till toppen

    Similar models

    Eligibility Squamous Cell Carcinoma NCT00476476

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Squamous cell carcinoma of vulva Measurable | Lesion of vulva Assessment | Neoplasm Metastasis Measurable | Primary tumor | Recurrent tumor | Operative Surgical Procedures Planned | Chemotherapy | Therapeutic radiology procedure
    Item
    histologically confirmed measurable squamous cell carcinoma of the vulvar with an assessable lesion on the vulva or measurable metastatic disease. tumors may be primary or recurrent. patients must have plans for surgery or definitive treatment with chemotherapy +/-radiation unless they have measurable metastatic disease.
    boolean
    C0280856 (UMLS CUI [1,1])
    C1513040 (UMLS CUI [1,2])
    C0221784 (UMLS CUI [2,1])
    C1516048 (UMLS CUI [2,2])
    C0027627 (UMLS CUI [3,1])
    C1513040 (UMLS CUI [3,2])
    C0677930 (UMLS CUI [4])
    C0521158 (UMLS CUI [5])
    C0543467 (UMLS CUI [6,1])
    C1301732 (UMLS CUI [6,2])
    C0392920 (UMLS CUI [7])
    C1522449 (UMLS CUI [8])
    Age
    Item
    18 years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    Chemotherapy Absent | Therapeutic radiology procedure Absent
    Item
    no concurrent chemotherapy or radiotherapy
    boolean
    C0392920 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Prior Chemotherapy Absent | Prior radiation therapy Absent
    Item
    no previous chemotherapy or radiotherapy within the preceding 1 month
    boolean
    C1514457 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0279134 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    ECOG performance status
    Item
    ecog performance status of 0-1
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity erlotinib
    Item
    known hypersensitivity reaction to erlotinib
    boolean
    C0020517 (UMLS CUI [1,1])
    C1135135 (UMLS CUI [1,2])
    Malignant Neoplasms | Basal cell carcinoma Excluded
    Item
    other coexisting malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma
    boolean
    C0006826 (UMLS CUI [1])
    C0007117 (UMLS CUI [2,1])
    C2828389 (UMLS CUI [2,2])
    Drugs, Non-Prescription | Investigational New Drugs
    Item
    treatment with a non-fda approved or investigational drug within 30 days
    boolean
    C0013231 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Prior Therapy | Toxicity persistent CTCAE Grades | Alopecia | Lymphedema
    Item
    persistent toxicities (grade 2 or above) from previous treatment, expect alopecia or lymphedema
    boolean
    C1514463 (UMLS CUI [1])
    C0600688 (UMLS CUI [2,1])
    C0205322 (UMLS CUI [2,2])
    C1516728 (UMLS CUI [2,3])
    C0002170 (UMLS CUI [3])
    C0024236 (UMLS CUI [4])
    Creatinine measurement, serum | CTCAE Grades
    Item
    serum creatinine level greater than ctc grade 2
    boolean
    C0201976 (UMLS CUI [1])
    C1516728 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnancy or breast feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Systemic disease Severe | Systemic disease Uncontrolled
    Item
    severe or uncontrolled systemic disease
    boolean
    C0442893 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0442893 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    Disease Study Subject Participation Status At risk | Laboratory test finding Study Subject Participation Status At risk
    Item
    significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
    boolean
    C0012634 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0587081 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    Tillbaka till toppen 

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