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ID

12119

Description

The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT; ODM derived from: https://clinicaltrials.gov/show/NCT02460887

Lien

https://clinicaltrials.gov/show/NCT02460887

Mots-clés

Versions (1)
  1. 24/09/2015 24/09/2015 - Julian Varghese
Téléchargé le

24 septembre 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Nasopharyngeal Carcinoma NCT02460887

    Anglais

    Eligibility Nasopharyngeal Carcinoma NCT02460887

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including who ii or iii).
    Description

    Nasopharyngeal Nonkeratinizing Carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1334926 (Nasopharyngeal Nonkeratinizing Carcinoma)
    tumor staged as t1-4n2-3或t3-4n0-1m0 (according to the 7th ajcc edition).
    Description

    AJCC tumor staging

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0441915 (AJCC tumor staging)
    SNOMED
    258236004
    LOINC
    LA4245-2
    satisfactory performance status: karnofsky scale (kps) ≥ 70.
    Description

    satisfactory performance status: karnofsky scale

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    adequate marrow: leucocyte count ≥ 4000/μl, hemoglobin ≥ 90g/l and platelet count ≥
    Description

    platelet count; hemoglobin

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    UMLS CUI [2]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    UMLS CUI [3]
    C0019046 (Hemoglobin)
    SNOMED
    38082009
    LOINC
    LP32067-8
    adequate liver function: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln
    Description

    alkaline phosphatase; concomitant; normal; liver; upper; ast; uln

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0376147 (SGPT - Glutamate pyruvate transaminase)
    UMLS CUI [2]
    C0242192 (SGOT - Glutamate oxaloacetate transaminase)
    UMLS CUI [3]
    C0201850 (Alkaline phosphatase measurement)
    SNOMED
    88810008
    and bilirubin ≤1.5×uln.
    Description

    bilirubin; uln

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    adequate renal function: creatinine clearance ≥ 60 ml/min.
    Description

    creatinine clearance; renal function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    patients must be informed of the investigational nature of this study and give written informed consent.
    Description

    written informed consent.; study

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
    Description

    Basaloid squamous cell carcinoma | Squamous cell carcinoma, keratinizing

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1266005 (Basaloid squamous cell carcinoma)
    SNOMED
    128634009
    UMLS CUI [2]
    C0334247 (Squamous cell carcinoma, keratinizing)
    SNOMED
    18048008
    treatment with palliative intent.
    Description

    palliative; treatment; intent

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C1285530 (Palliative)
    SNOMED
    363676003
    prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
    Description

    prior malignancy; cervical; squamous; cancer; skin

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
    Description

    Patient currently pregnant | Lactating (finding)

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [2]
    C2828358 (Lactating (finding))
    history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
    Description

    history of previous rt

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
    Description

    prior chemotherapy; primary tumor; surgery; nodes

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2,1]
    C0038894 (Surgery specialty)
    UMLS CUI [2,2]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×uln), and emotional disturbance.
    Description

    Disease condition determination, uncontrolled | Compliance behavior | Heart Diseases; Unstable status | Kidney Diseases | Hepatitis, Chronic | Diabetes mellitus poor control | Emotional Disturbances

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0184774 (Disease condition determination, uncontrolled)
    SNOMED
    28876000
    UMLS CUI [2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [3,1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    UMLS CUI [3,2]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
    UMLS CUI [4]
    C0022658 (Kidney Diseases)
    SNOMED
    90708001
    UMLS CUI [5]
    C0019189 (Hepatitis, Chronic)
    SNOMED
    76783007
    UMLS CUI [6]
    C0860161 (Diabetes mellitus poor control)
    UMLS CUI [7]
    C0013985 (Emotional Disturbances)
    Retour au début de la page

    Similar models

    Eligibility Nasopharyngeal Carcinoma NCT02460887

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Nasopharyngeal Nonkeratinizing Carcinoma
    Item
    patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including who ii or iii).
    boolean
    C1334926 (UMLS CUI [1])
    AJCC tumor staging
    Item
    tumor staged as t1-4n2-3或t3-4n0-1m0 (according to the 7th ajcc edition).
    boolean
    C0441915 (UMLS CUI [1])
    satisfactory performance status: karnofsky scale
    Item
    satisfactory performance status: karnofsky scale (kps) ≥ 70.
    boolean
    C1520224 (UMLS CUI [1])
    platelet count; hemoglobin
    Item
    adequate marrow: leucocyte count ≥ 4000/μl, hemoglobin ≥ 90g/l and platelet count ≥
    boolean
    C0023508 (UMLS CUI [1])
    C0005821 (UMLS CUI [2])
    C0019046 (UMLS CUI [3])
    alkaline phosphatase; concomitant; normal; liver; upper; ast; uln
    Item
    adequate liver function: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln
    boolean
    C0376147 (UMLS CUI [1])
    C0242192 (UMLS CUI [2])
    C0201850 (UMLS CUI [3])
    bilirubin; uln
    Item
    and bilirubin ≤1.5×uln.
    boolean
    C1278039 (UMLS CUI [1])
    creatinine clearance; renal function
    Item
    adequate renal function: creatinine clearance ≥ 60 ml/min.
    boolean
    C0373595 (UMLS CUI [1])
    written informed consent.; study
    Item
    patients must be informed of the investigational nature of this study and give written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Basaloid squamous cell carcinoma | Squamous cell carcinoma, keratinizing
    Item
    who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
    boolean
    C1266005 (UMLS CUI [1])
    C0334247 (UMLS CUI [2])
    palliative; treatment; intent
    Item
    treatment with palliative intent.
    boolean
    C0087111 (UMLS CUI [1,1])
    C1285530 (UMLS CUI [1,2])
    prior malignancy; cervical; squamous; cancer; skin
    Item
    prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
    boolean
    C0006826 (UMLS CUI [1])
    Patient currently pregnant | Lactating (finding)
    Item
    pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
    boolean
    C0549206 (UMLS CUI [1])
    C2828358 (UMLS CUI [2])
    history of previous rt
    Item
    history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
    boolean
    C1522449 (UMLS CUI [1])
    prior chemotherapy; primary tumor; surgery; nodes
    Item
    prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
    boolean
    C0392920 (UMLS CUI [1])
    C0038894 (UMLS CUI [2,1])
    C0006826 (UMLS CUI [2,2])
    Disease condition determination, uncontrolled | Compliance behavior | Heart Diseases; Unstable status | Kidney Diseases | Hepatitis, Chronic | Diabetes mellitus poor control | Emotional Disturbances
    Item
    any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×uln), and emotional disturbance.
    boolean
    C0184774 (UMLS CUI [1])
    C1321605 (UMLS CUI [2])
    C0018799 (UMLS CUI [3,1])
    C0443343 (UMLS CUI [3,2])
    C0022658 (UMLS CUI [4])
    C0019189 (UMLS CUI [5])
    C0860161 (UMLS CUI [6])
    C0013985 (UMLS CUI [7])
    Retour au début de la page 

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