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ID

12911

Descrizione

Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT00139269

collegamento

https://clinicaltrials.gov/show/NCT00139269

Keywords

  1. 6/1/16 6/1/16 -
Titolare del copyright

CC BY-NC 3.0

Caricato su

6 de enero de 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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    Eligibility Advanced Squamous Cell Carcinoma NCT00139269

    Eligibility Advanced Squamous Cell Carcinoma NCT00139269

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (sschn).
    Descrizione

    Diagnosis of squamous cell carcinoma

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0007137 (Squamous cell carcinoma)
    SNOMED
    28899001
    LOINC
    LP17968-6
    at least one bi- or uni-dimensionally measurable lesion.
    Descrizione

    Lesion

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0221198 (Lesion)
    SNOMED
    52988006
    stage ii or iv disease without evidence of distant metastasis.
    Descrizione

    Stage

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1300072 (Tumor stage)
    SNOMED
    371508000
    no previous chemotherapy, radiotherapy or surgery (other than biopsy) for sschn.
    Descrizione

    Prior therapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    age greater than 18 years.
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status of 0 or 1.
    Descrizione

    ECOG

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    life expectancy of greater than 12 weeks.
    Descrizione

    life expectancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    adequate bone marrow, hepatic and renal function.
    Descrizione

    Organ function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0678852 (body system or organ function)
    normal serum calcium
    Descrizione

    Calcium

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201925 (Calcium measurement)
    SNOMED
    71878006
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
    Descrizione

    Tumor location

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0872338 (cancer location)
    patients with any non-sschn malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
    Descrizione

    Other malignancies

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    any prior treatment with chemotherapy.
    Descrizione

    chemotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    prior radiotherapy to major bone marrow area (> 10% bone marrow) or to head and neck.
    Descrizione

    radiotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    current peripheral neuropathy of greater than nci grade 2.
    Descrizione

    peripheral neuropathy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0031117 (Peripheral Neuropathy)
    other serious illness or medical condition
    Descrizione

    Comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    concurrent treatment with corticosteroids unless chronic treatment at low doses.
    Descrizione

    corticosteroids

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001617 (Adrenal Cortex Hormones)
    SNOMED
    21568003
    LOINC
    LP20687-7
    pregnant or lactating females or females of childbearing potential not employing adequate contraception.
    Descrizione

    Pregnancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6

    Similar models

    Eligibility Advanced Squamous Cell Carcinoma NCT00139269

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diagnosis of squamous cell carcinoma
    Item
    histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (sschn).
    boolean
    C0007137 (UMLS CUI [1])
    Lesion
    Item
    at least one bi- or uni-dimensionally measurable lesion.
    boolean
    C0221198 (UMLS CUI [1])
    Stage
    Item
    stage ii or iv disease without evidence of distant metastasis.
    boolean
    C1300072 (UMLS CUI [1])
    Prior therapy
    Item
    no previous chemotherapy, radiotherapy or surgery (other than biopsy) for sschn.
    boolean
    C0087111 (UMLS CUI [1])
    Age
    Item
    age greater than 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    ECOG
    Item
    ecog performance status of 0 or 1.
    boolean
    C1520224 (UMLS CUI [1])
    life expectancy
    Item
    life expectancy of greater than 12 weeks.
    boolean
    C0023671 (UMLS CUI [1])
    Organ function
    Item
    adequate bone marrow, hepatic and renal function.
    boolean
    C0678852 (UMLS CUI [1])
    Calcium
    Item
    normal serum calcium
    boolean
    C0201925 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Tumor location
    Item
    primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
    boolean
    C0872338 (UMLS CUI [1])
    Other malignancies
    Item
    patients with any non-sschn malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
    boolean
    C0006826 (UMLS CUI [1])
    chemotherapy
    Item
    any prior treatment with chemotherapy.
    boolean
    C0392920 (UMLS CUI [1])
    radiotherapy
    Item
    prior radiotherapy to major bone marrow area (> 10% bone marrow) or to head and neck.
    boolean
    C1522449 (UMLS CUI [1])
    peripheral neuropathy
    Item
    current peripheral neuropathy of greater than nci grade 2.
    boolean
    C0031117 (UMLS CUI [1])
    Comorbidity
    Item
    other serious illness or medical condition
    boolean
    C0009488 (UMLS CUI [1])
    corticosteroids
    Item
    concurrent treatment with corticosteroids unless chronic treatment at low doses.
    boolean
    C0001617 (UMLS CUI [1])
    Pregnancy
    Item
    pregnant or lactating females or females of childbearing potential not employing adequate contraception.
    boolean
    C0032961 (UMLS CUI [1])

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