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ID

39345

Description

Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01425736

Link

https://clinicaltrials.gov/show/NCT01425736

Keywords

Versions (1)
  1. 12/23/19 12/23/19 -
Copyright Holder

See clinicaltrials.gov

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December 23, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

    English

    Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    joined the study voluntary and signed informed consent form
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    age 18-75，both genders.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    had histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck
    Description

    Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4524839
    UMLS CUI [2]
    C0744620
    at least one lesions can be measured,conventional measurements ≥2cm, computed tomography(ct) examination ≥1cm .
    Description

    Measurable Disease Quantity | Lesion size Measurement conventional | Lesion size Computed Tomography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [2,1]
    C0449453
    UMLS CUI [2,2]
    C0242485
    UMLS CUI [2,3]
    C0439858
    UMLS CUI [3,1]
    C0449453
    UMLS CUI [3,2]
    C0040405
    eastern cooperative oncology group(ecog) performance scale 0-2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy of more than 3 months.
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
    Description

    Gender | At risk of unplanned pregnancy Contraceptive method

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C3839721
    UMLS CUI [2,2]
    C0700589
    haemoglobin≥90g/l ,white blood cell(wbc) ≥3×10^9/l
    Description

    Hemoglobin measurement | White Blood Cell Count procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    UMLS CUI [2]
    C0023508
    hepatic function:alat、asat< 2.5 x uln, tbil< 1.5 x uln
    Description

    Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C1278039
    renal function: creatinine < 1.5 x uln
    Description

    Renal function | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    received other anti egfr monoclonal antibody treatment
    Description

    Anti-EGFR monoclonal antibody therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4316122
    participation in other interventional clinical trials within 1 month
    Description

    Study Subject Participation Status | Interventional procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0184661
    previous received other drug or operative treatment within 6 month
    Description

    Pharmacotherapy Other | Operative Surgical Procedure Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2,1]
    C0543467
    UMLS CUI [2,2]
    C0205394
    pregnant or breast-feeding women
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    history of serious allergic or allergy
    Description

    Hypersensitivity Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0205404
    patients with the history of serious lung or head disease
    Description

    Lung disease Serious | Disorder of head Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024115
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C1290856
    UMLS CUI [2,2]
    C0205404
    other malignant tumor
    Description

    Cancer Other

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    not primary tumor(except for primary tumor therapy>3months)
    Description

    Neoplasm Except Primary tumor

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0677930
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    Similar models

    Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    joined the study voluntary and signed informed consent form
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    age 18-75，both genders.
    boolean
    C0001779 (UMLS CUI [1])
    Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC
    Item
    had histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck
    boolean
    C4524839 (UMLS CUI [1])
    C0744620 (UMLS CUI [2])
    Measurable Disease Quantity | Lesion size Measurement conventional | Lesion size Computed Tomography
    Item
    at least one lesions can be measured,conventional measurements ≥2cm, computed tomography(ct) examination ≥1cm .
    boolean
    C1513041 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0449453 (UMLS CUI [2,1])
    C0242485 (UMLS CUI [2,2])
    C0439858 (UMLS CUI [2,3])
    C0449453 (UMLS CUI [3,1])
    C0040405 (UMLS CUI [3,2])
    ECOG performance status
    Item
    eastern cooperative oncology group(ecog) performance scale 0-2.
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy of more than 3 months.
    boolean
    C0023671 (UMLS CUI [1])
    Gender | At risk of unplanned pregnancy Contraceptive method
    Item
    use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
    boolean
    C0079399 (UMLS CUI [1])
    C3839721 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Hemoglobin measurement | White Blood Cell Count procedure
    Item
    haemoglobin≥90g/l ,white blood cell(wbc) ≥3×10^9/l
    boolean
    C0518015 (UMLS CUI [1])
    C0023508 (UMLS CUI [2])
    Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
    Item
    hepatic function:alat、asat< 2.5 x uln, tbil< 1.5 x uln
    boolean
    C0232741 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    Renal function | Creatinine measurement, serum
    Item
    renal function: creatinine < 1.5 x uln
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Anti-EGFR monoclonal antibody therapy
    Item
    received other anti egfr monoclonal antibody treatment
    boolean
    C4316122 (UMLS CUI [1])
    Study Subject Participation Status | Interventional procedure
    Item
    participation in other interventional clinical trials within 1 month
    boolean
    C2348568 (UMLS CUI [1])
    C0184661 (UMLS CUI [2])
    Pharmacotherapy Other | Operative Surgical Procedure Other
    Item
    previous received other drug or operative treatment within 6 month
    boolean
    C0013216 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Pregnancy | Breast Feeding
    Item
    pregnant or breast-feeding women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Hypersensitivity Serious
    Item
    history of serious allergic or allergy
    boolean
    C0020517 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    Lung disease Serious | Disorder of head Serious
    Item
    patients with the history of serious lung or head disease
    boolean
    C0024115 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C1290856 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    Cancer Other
    Item
    other malignant tumor
    boolean
    C1707251 (UMLS CUI [1])
    Neoplasm Except Primary tumor
    Item
    not primary tumor(except for primary tumor therapy>3months)
    boolean
    C0027651 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0677930 (UMLS CUI [1,3])
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