0 Ratings
ID

12911

Description

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

Link

https://clinicaltrials.gov/show/NCT00139269

Keywords

Versions (1)
  1. 1/6/16 1/6/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 6, 2016

DOI

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License

Creative Commons BY-NC 3.0
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    Eligibility Advanced Squamous Cell Carcinoma NCT00139269

    English

    Eligibility Advanced Squamous Cell Carcinoma NCT00139269

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    Diagnosis of squamous cell carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007137
    at least one bi- or uni-dimensionally measurable lesion.
    Description

    Lesion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221198
    stage ii or iv disease without evidence of distant metastasis.
    Description

    Stage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1300072
    no previous chemotherapy, radiotherapy or surgery (other than biopsy) for sschn.
    Description

    Prior therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    age greater than 18 years.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog performance status of 0 or 1.
    Description

    ECOG

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy of greater than 12 weeks.
    Description

    life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    adequate bone marrow, hepatic and renal function.
    Description

    Organ function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    normal serum calcium
    Description

    Calcium

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201925
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
    Description

    Tumor location

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0872338
    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.
    Description

    Other malignancies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    any prior treatment with chemotherapy.
    Description

    chemotherapy

    Data type

    boolean

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

    radiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    current peripheral neuropathy of greater than nci grade 2.
    Description

    peripheral neuropathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031117
    other serious illness or medical condition
    Description

    Comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    concurrent treatment with corticosteroids unless chronic treatment at low doses.
    Description

    corticosteroids

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    pregnant or lactating females or females of childbearing potential not employing adequate contraception.
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Eligibility Advanced Squamous Cell Carcinoma NCT00139269

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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