0 Ratings

ID

18322

Description

A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839; ODM derived from: https://clinicaltrials.gov/show/NCT00212108

Link

https://clinicaltrials.gov/show/NCT00212108

Keywords

  1. 10/31/16 10/31/16 -
  2. 10/31/16 10/31/16 -
Uploaded on

October 31, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility Nasopharyngeal Carcinoma NCT00212108

    Eligibility Nasopharyngeal Carcinoma NCT00212108

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. histologically proven npc.
    Description

    Nasopharyngeal carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2931822
    2. any clinical stage npc as defined by the ajcc/uicc system.
    Description

    Nasopharyngeal carcinoma | TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2931822
    UMLS CUI [2]
    C3258246
    3. no prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
    Description

    Therapeutic radiology procedure | Chemoradiotherapy | Immunotherapy | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2]
    C0436307
    UMLS CUI [3]
    C0021083
    UMLS CUI [4]
    C0013230
    4. no prior nsaids or corticosteroids for at least 4 weeks.
    Description

    Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003211
    UMLS CUI [2]
    C0001617
    5. ecog performance status ≤ 2.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    6. adequate end organ function
    Description

    organ function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    7. life expectancy > 3 months.
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    8. signed informed consent -
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
    Description

    celecoxib Take Unable | gefitinib Take Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0538927
    UMLS CUI [1,2]
    C1290952
    UMLS CUI [1,3]
    C1299582
    UMLS CUI [2,1]
    C1122962
    UMLS CUI [2,2]
    C1290952
    UMLS CUI [2,3]
    C1299582
    2. tumor not visible on fibre nasopharyngoscopy for biopsy.
    Description

    Neoplasm Visible | Nasopharyngoscopy | Biopsy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0205379
    UMLS CUI [2]
    C0189025
    UMLS CUI [3]
    C0005558
    3. known peptic ulcer disease.
    Description

    Peptic Ulcer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030920
    4. evidence of clinically active interstitial lung disease.
    Description

    Interstitial Lung Disease Evidence of

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0206062
    UMLS CUI [1,2]
    C0332120
    5. previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
    Description

    Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C0851140
    UMLS CUI [2,2]
    C1522326
    UMLS CUI [3,1]
    C0007117
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [4,1]
    C0553723
    UMLS CUI [4,2]
    C1522326
    6. women who are pregnant or lactating. females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
    Description

    Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0430061
    7. women of childbearing potential who are not practising adequate contraception.
    Description

    Childbearing Potential Contraceptive methods Lacking

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [1,3]
    C0332268
    8. concurrent medical problems that would significantly limit compliance with the study.
    Description

    Comorbidity Compliance behavior Limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C1321605
    UMLS CUI [1,3]
    C0439801
    9. presence of any underlying medical conditions (eg. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
    Description

    Medical condition Resulting in Study Subject Participation Status Inappropriate | Respiration Disorder Unstable | Respiration Disorder Uncompensated | Heart Disease Unstable | Heart Disease Uncompensated | Kidney Disease Unstable | Kidney Disease Uncompensated | Liver disease Unstable | Liver disease Uncompensated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0332294
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [1,4]
    C1548788
    UMLS CUI [2,1]
    C0035204
    UMLS CUI [2,2]
    C0443343
    UMLS CUI [3,1]
    C0035204
    UMLS CUI [3,2]
    C0205433
    UMLS CUI [4,1]
    C0018799
    UMLS CUI [4,2]
    C0443343
    UMLS CUI [5,1]
    C0018799
    UMLS CUI [5,2]
    C0205433
    UMLS CUI [6,1]
    C0022658
    UMLS CUI [6,2]
    C0443343
    UMLS CUI [7,1]
    C0022658
    UMLS CUI [7,2]
    C0205433
    UMLS CUI [8,1]
    C0023895
    UMLS CUI [8,2]
    C0443343
    UMLS CUI [9,1]
    C0023895
    UMLS CUI [9,2]
    C0205433
    10. known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of nsaids.
    Description

    Hypersensitivity celecoxib | Hypersensitivity gefitinib | Hypersensitivity celecoxib Excipient | Hypersensitivity gefitinib Excipient | Allergy to sulfonamides | Allergic Reaction NSAIDS Ingestion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0538927
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C1122962
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0538927
    UMLS CUI [3,3]
    C0015237
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C1122962
    UMLS CUI [4,3]
    C0015237
    UMLS CUI [5]
    C0038757
    UMLS CUI [6,1]
    C1527304
    UMLS CUI [6,2]
    C0003211
    UMLS CUI [6,3]
    C0232478
    11. known hiv, hbv or hcv infection. -
    Description

    HIV Infections | Hepatitis B | Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196

    Similar models

    Eligibility Nasopharyngeal Carcinoma NCT00212108

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Nasopharyngeal carcinoma
    Item
    1. histologically proven npc.
    boolean
    C2931822 (UMLS CUI [1])
    Nasopharyngeal carcinoma | TNM clinical staging
    Item
    2. any clinical stage npc as defined by the ajcc/uicc system.
    boolean
    C2931822 (UMLS CUI [1])
    C3258246 (UMLS CUI [2])
    Therapeutic radiology procedure | Chemoradiotherapy | Immunotherapy | Investigational New Drugs
    Item
    3. no prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
    boolean
    C1522449 (UMLS CUI [1])
    C0436307 (UMLS CUI [2])
    C0021083 (UMLS CUI [3])
    C0013230 (UMLS CUI [4])
    Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones
    Item
    4. no prior nsaids or corticosteroids for at least 4 weeks.
    boolean
    C0003211 (UMLS CUI [1])
    C0001617 (UMLS CUI [2])
    ECOG performance status
    Item
    5. ecog performance status ≤ 2.
    boolean
    C1520224 (UMLS CUI [1])
    organ function
    Item
    6. adequate end organ function
    boolean
    C0678852 (UMLS CUI [1])
    Life Expectancy
    Item
    7. life expectancy > 3 months.
    boolean
    C0023671 (UMLS CUI [1])
    Informed Consent
    Item
    8. signed informed consent -
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    celecoxib Take Unable | gefitinib Take Unable
    Item
    1. inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
    boolean
    C0538927 (UMLS CUI [1,1])
    C1290952 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
    C1122962 (UMLS CUI [2,1])
    C1290952 (UMLS CUI [2,2])
    C1299582 (UMLS CUI [2,3])
    Neoplasm Visible | Nasopharyngoscopy | Biopsy
    Item
    2. tumor not visible on fibre nasopharyngoscopy for biopsy.
    boolean
    C0027651 (UMLS CUI [1,1])
    C0205379 (UMLS CUI [1,2])
    C0189025 (UMLS CUI [2])
    C0005558 (UMLS CUI [3])
    Peptic Ulcer
    Item
    3. known peptic ulcer disease.
    boolean
    C0030920 (UMLS CUI [1])
    Interstitial Lung Disease Evidence of
    Item
    4. evidence of clinically active interstitial lung disease.
    boolean
    C0206062 (UMLS CUI [1,1])
    C0332120 (UMLS CUI [1,2])
    Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
    Item
    5. previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
    boolean
    C0006826 (UMLS CUI [1])
    C0851140 (UMLS CUI [2,1])
    C1522326 (UMLS CUI [2,2])
    C0007117 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0553723 (UMLS CUI [4,1])
    C1522326 (UMLS CUI [4,2])
    Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative
    Item
    6. women who are pregnant or lactating. females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0430061 (UMLS CUI [3,2])
    Childbearing Potential Contraceptive methods Lacking
    Item
    7. women of childbearing potential who are not practising adequate contraception.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0332268 (UMLS CUI [1,3])
    Comorbidity Compliance behavior Limited
    Item
    8. concurrent medical problems that would significantly limit compliance with the study.
    boolean
    C0009488 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    Medical condition Resulting in Study Subject Participation Status Inappropriate | Respiration Disorder Unstable | Respiration Disorder Uncompensated | Heart Disease Unstable | Heart Disease Uncompensated | Kidney Disease Unstable | Kidney Disease Uncompensated | Liver disease Unstable | Liver disease Uncompensated
    Item
    9. presence of any underlying medical conditions (eg. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0332294 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C1548788 (UMLS CUI [1,4])
    C0035204 (UMLS CUI [2,1])
    C0443343 (UMLS CUI [2,2])
    C0035204 (UMLS CUI [3,1])
    C0205433 (UMLS CUI [3,2])
    C0018799 (UMLS CUI [4,1])
    C0443343 (UMLS CUI [4,2])
    C0018799 (UMLS CUI [5,1])
    C0205433 (UMLS CUI [5,2])
    C0022658 (UMLS CUI [6,1])
    C0443343 (UMLS CUI [6,2])
    C0022658 (UMLS CUI [7,1])
    C0205433 (UMLS CUI [7,2])
    C0023895 (UMLS CUI [8,1])
    C0443343 (UMLS CUI [8,2])
    C0023895 (UMLS CUI [9,1])
    C0205433 (UMLS CUI [9,2])
    Hypersensitivity celecoxib | Hypersensitivity gefitinib | Hypersensitivity celecoxib Excipient | Hypersensitivity gefitinib Excipient | Allergy to sulfonamides | Allergic Reaction NSAIDS Ingestion
    Item
    10. known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of nsaids.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0538927 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C1122962 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0538927 (UMLS CUI [3,2])
    C0015237 (UMLS CUI [3,3])
    C0020517 (UMLS CUI [4,1])
    C1122962 (UMLS CUI [4,2])
    C0015237 (UMLS CUI [4,3])
    C0038757 (UMLS CUI [5])
    C1527304 (UMLS CUI [6,1])
    C0003211 (UMLS CUI [6,2])
    C0232478 (UMLS CUI [6,3])
    HIV Infections | Hepatitis B | Hepatitis C
    Item
    11. known hiv, hbv or hcv infection. -
    boolean
    C0019693 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial