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ID

36553

Description

Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02016417

Link

https://clinicaltrials.gov/show/NCT02016417

Keywords

Versions (2)
  1. 5/21/19 5/21/19 -
  2. 5/21/19 5/21/19 -
Copyright Holder

See clinicaltrials.gov

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May 21, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Nasopharyngeal Carcinoma NCT02016417

    English

    Eligibility Nasopharyngeal Carcinoma NCT02016417

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients with newly histologically confirmed non-keratinizing (according to who histologically type).
    Description

    Nasopharyngeal Nonkeratinizing Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1334926
    2. 18 years to 70 years;
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. tumor staged as t3-4n1/n2-3m0 (according to the 7th ajcc edition),
    Description

    Neoplasm TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C3258246
    4. performance status: karnofsky scale (kps) > 70 (appendix i ).
    Description

    Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    5. adequate marrow: leucocyte count > 4×109/l, neutrophil count > 2×109/l, hemoglobin > 90g/l and platelet count > 100×109/l.
    Description

    Bone Marrow function | White Blood Cell Count procedure | Neutrophil count (procedure) | Hemoglobin measurement | Platelet Count measurement

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0023508
    UMLS CUI [3]
    C0200633
    UMLS CUI [4]
    C0518015
    UMLS CUI [5]
    C0032181
    6. normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) < 2.5×uln, and bilirubin < uln.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C0201850
    UMLS CUI [5]
    C1278039
    7. adequate renal function: creatinine clearance > 60 ml/min.
    Description

    Renal function | Creatinine clearance measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0373595
    8. patients must be informed of the investigational nature of this study and give written informed consent.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
    Description

    Squamous cell carcinoma, keratinizing | Basaloid squamous cell carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0334247
    UMLS CUI [2]
    C1266005
    2. age > 70 or < 18.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. treatment with palliative intent.
    Description

    Therapeutic procedure Palliative intent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1285530
    4. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0007117
    UMLS CUI [2,3]
    C1522326
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0553723
    UMLS CUI [3,3]
    C1522326
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0851140
    5. pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
    Description

    Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests | Childbearing Potential Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0032976
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0700589
    6. history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
    Description

    Prior radiation therapy | Exception Therapeutic radiology procedure Skin carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0279134
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1522449
    UMLS CUI [2,3]
    C0699893
    7. prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
    Description

    Prior Chemotherapy Primary tumor | Operative Surgical Procedures Primary tumor | Prior Chemotherapy Lymph nodes | Operative Surgical Procedures Lymph nodes | Exception Diagnostic procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2,1]
    C0543467
    UMLS CUI [2,2]
    C0677930
    UMLS CUI [3,1]
    C1514457
    UMLS CUI [3,2]
    C0024204
    UMLS CUI [4,1]
    C0543467
    UMLS CUI [4,2]
    C0024204
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0430022
    8. 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

    Comorbidity Severe At risk Clinical Trial | Comorbidity Severe Affecting Clinical Trial | Heart Disease Unstable Treatment required for | Kidney Disease | Hepatitis, Chronic | Diabetes mellitus poor control | Elevated fasting plasma glucose | Emotional Disturbance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [1,4]
    C0008976
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C0392760
    UMLS CUI [2,4]
    C0008976
    UMLS CUI [3,1]
    C0018799
    UMLS CUI [3,2]
    C0443343
    UMLS CUI [3,3]
    C0332121
    UMLS CUI [4]
    C0022658
    UMLS CUI [5]
    C0019189
    UMLS CUI [6]
    C0860161
    UMLS CUI [7]
    C4228506
    UMLS CUI [8]
    C0013985
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    Similar models

    Eligibility Nasopharyngeal Carcinoma NCT02016417

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Nasopharyngeal Nonkeratinizing Carcinoma
    Item
    1. patients with newly histologically confirmed non-keratinizing (according to who histologically type).
    boolean
    C1334926 (UMLS CUI [1])
    Age
    Item
    2. 18 years to 70 years;
    boolean
    C0001779 (UMLS CUI [1])
    Neoplasm TNM clinical staging
    Item
    3. tumor staged as t3-4n1/n2-3m0 (according to the 7th ajcc edition),
    boolean
    C0027651 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    Karnofsky Performance Status
    Item
    4. performance status: karnofsky scale (kps) > 70 (appendix i ).
    boolean
    C0206065 (UMLS CUI [1])
    Bone Marrow function | White Blood Cell Count procedure | Neutrophil count (procedure) | Hemoglobin measurement | Platelet Count measurement
    Item
    5. adequate marrow: leucocyte count > 4×109/l, neutrophil count > 2×109/l, hemoglobin > 90g/l and platelet count > 100×109/l.
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0023508 (UMLS CUI [2])
    C0200633 (UMLS CUI [3])
    C0518015 (UMLS CUI [4])
    C0032181 (UMLS CUI [5])
    Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement
    Item
    6. normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) < 2.5×uln, and bilirubin < uln.
    boolean
    C0232741 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201850 (UMLS CUI [4])
    C1278039 (UMLS CUI [5])
    Renal function | Creatinine clearance measurement
    Item
    7. adequate renal function: creatinine clearance > 60 ml/min.
    boolean
    C0232804 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    Informed Consent
    Item
    8. 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)
    Squamous cell carcinoma, keratinizing | Basaloid squamous cell carcinoma
    Item
    1. who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
    boolean
    C0334247 (UMLS CUI [1])
    C1266005 (UMLS CUI [2])
    Age
    Item
    2. age > 70 or < 18.
    boolean
    C0001779 (UMLS CUI [1])
    Therapeutic procedure Palliative intent
    Item
    3. treatment with palliative intent.
    boolean
    C0087111 (UMLS CUI [1,1])
    C1285530 (UMLS CUI [1,2])
    Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix
    Item
    4. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0007117 (UMLS CUI [2,2])
    C1522326 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0553723 (UMLS CUI [3,2])
    C1522326 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0851140 (UMLS CUI [4,2])
    Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests | Childbearing Potential Contraceptive methods
    Item
    5. pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0032976 (UMLS CUI [3,2])
    C3831118 (UMLS CUI [4,1])
    C0700589 (UMLS CUI [4,2])
    Prior radiation therapy | Exception Therapeutic radiology procedure Skin carcinoma
    Item
    6. history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
    boolean
    C0279134 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
    C0699893 (UMLS CUI [2,3])
    Prior Chemotherapy Primary tumor | Operative Surgical Procedures Primary tumor | Prior Chemotherapy Lymph nodes | Operative Surgical Procedures Lymph nodes | Exception Diagnostic procedure
    Item
    7. prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
    boolean
    C1514457 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2,1])
    C0677930 (UMLS CUI [2,2])
    C1514457 (UMLS CUI [3,1])
    C0024204 (UMLS CUI [3,2])
    C0543467 (UMLS CUI [4,1])
    C0024204 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C0430022 (UMLS CUI [5,2])
    Comorbidity Severe At risk Clinical Trial | Comorbidity Severe Affecting Clinical Trial | Heart Disease Unstable Treatment required for | Kidney Disease | Hepatitis, Chronic | Diabetes mellitus poor control | Elevated fasting plasma glucose | Emotional Disturbance
    Item
    8. 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
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0008976 (UMLS CUI [1,4])
    C0009488 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0392760 (UMLS CUI [2,3])
    C0008976 (UMLS CUI [2,4])
    C0018799 (UMLS CUI [3,1])
    C0443343 (UMLS CUI [3,2])
    C0332121 (UMLS CUI [3,3])
    C0022658 (UMLS CUI [4])
    C0019189 (UMLS CUI [5])
    C0860161 (UMLS CUI [6])
    C4228506 (UMLS CUI [7])
    C0013985 (UMLS CUI [8])
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