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ID

17392

Beskrivning

Celecoxib/Oxaliplatin/Capecitabine for Gastric/GE Junction Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00256321

Länk

https://clinicaltrials.gov/show/NCT00256321

Nyckelord

  1. 2016-09-11 2016-09-11 -
Uppladdad den

11 september 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Gastric Carcinoma NCT00256321

    Eligibility Gastric Carcinoma NCT00256321

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patient must have histologically proven, pathologically verified and surgically incurable(unresectable, recurrent, or metastatic) gastric/gastroesophageal junction carcinoma. gastric lymphoma and gastrointestinal stromal tumor(gist) are ineligible for this study. at least 6 unstained paraffin-embedded pathologic specimen slides will be required for the cox-2 expression assays.
    Beskrivning

    Stomach Carcinoma unresectable | recurrent gastric cancer | Stomach Carcinoma Metastatic | Gastrooesophageal cancer unresectable | Gastrooesophageal cancer Recurrent | Gastrooesophageal cancer Metastatic | Gastric lymphoma | Gastrointestinal Stromal Tumors | Unstained Specimen Paraffin Embedding | COX-2 Expression Analysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0699791 (Stomach Carcinoma)
    SNOMED
    372143007
    UMLS CUI [1,2]
    C1519810 (Unresectable)
    UMLS CUI [2]
    C0278502 (recurrent gastric cancer)
    UMLS CUI [3,1]
    C0699791 (Stomach Carcinoma)
    SNOMED
    372143007
    UMLS CUI [3,2]
    C0036525 (Metastatic to)
    SNOMED
    77879006
    UMLS CUI [4,1]
    C1112160 (Gastrooesophageal cancer)
    UMLS CUI [4,2]
    C1519810 (Unresectable)
    UMLS CUI [5,1]
    C1112160 (Gastrooesophageal cancer)
    UMLS CUI [5,2]
    C2945760 (Recurrent)
    SNOMED
    255227004
    UMLS CUI [6,1]
    C1112160 (Gastrooesophageal cancer)
    UMLS CUI [6,2]
    C0036525 (Metastatic to)
    SNOMED
    77879006
    UMLS CUI [7]
    C0349532 (Gastric lymphoma)
    SNOMED
    276811008
    UMLS CUI [8]
    C0238198 (Gastrointestinal Stromal Tumors)
    SNOMED
    128755003
    UMLS CUI [9,1]
    C1883469 (Unstained Specimen)
    UMLS CUI [9,2]
    C0085185 (Paraffin Embedding)
    SNOMED
    702941008
    UMLS CUI [10]
    C2827630 (COX-2 Immunohistochemical Expression Analysis)
    patient must have bidimensionally measurable disease as defined in section 10.1a. all measurable lesions must be assessed (by physical examination, ct scan, radionuclide scan or plain x-ray) within 30 days prior to registration. the patient's disease status must be completely assessed and reported.
    Beskrivning

    2-Dimensional Measurable Disease | Physical Examination | X-Ray Computed Tomography | Radionuclide Imaging | Plain x-ray

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041 (Measurable Disease)
    UMLS CUI [1,2]
    C1705052 (2-Dimensional)
    LOINC
    LA19769-1
    UMLS CUI [2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [3]
    C0040405 (X-Ray Computed Tomography)
    SNOMED
    77477000
    LOINC
    LP6207-7
    UMLS CUI [4]
    C0034606 (Radionuclide Imaging)
    SNOMED
    373205008
    UMLS CUI [5]
    C1306645 (Plain x-ray)
    SNOMED
    168537006
    all patients must undergo a ct of abdomen and chest within 30 days prior to registration.
    Beskrivning

    CT of abdomen | Chest CT

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0412620 (CT of abdomen)
    SNOMED
    169070004
    UMLS CUI [2]
    C0202823 (Chest CT)
    SNOMED
    169069000
    patients with brain metastases are not eligible for this study. it is not mandatory to obtain brain ct or mri on all patients. however, patients who exhibit neurological symptoms or have pulmonary metastases on radiographic studies must obtain brain ct w/ iv contrast or mri prior to registration to ascertain the presence of brain metastasis.
    Beskrivning

    Metastatic malignant neoplasm to brain | brain ct | brain MRI | Neurologic Symptoms | Secondary malignant neoplasm of lung | Radiography | Brain MRI W contrast IV

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    UMLS CUI [2]
    C0412585 (CAT scan of brain)
    SNOMED
    34227000
    UMLS CUI [3]
    C0412675 (Magnetic resonance imaging of brain and brain stem)
    SNOMED
    29567006
    UMLS CUI [4]
    C0235031 (Neurologic Symptoms)
    SNOMED
    267070008
    UMLS CUI [5]
    C0153676 (Secondary malignant neoplasm of lung)
    SNOMED
    94391008
    UMLS CUI [6]
    C0034571 (roentgenographic)
    UMLS CUI [7]
    C0881826 (Multisection^W contrast IV:Find:Pt:Head>Brain:Doc:MR)
    LOINC
    24589-4
    patients must not have received capecitabine or oxaliplatin. prior use of cisplatin, carboplatin, 5-fu are permitted. prior systemic therapy must have been completed at least 30 days before registration.
    Beskrivning

    capecitabine | oxaliplatin | Cisplatin | Carboplatin | Fluorouracil | systemic therapy Completed

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0671970 (capecitabine)
    SNOMED
    108761006
    UMLS CUI [2]
    C0069717 (oxaliplatin)
    SNOMED
    327032007
    UMLS CUI [3]
    C0008838 (cisplatin)
    SNOMED
    387318005
    UMLS CUI [4]
    C0079083 (carboplatin)
    SNOMED
    108759002
    UMLS CUI [5]
    C0016360 (fluorouracil)
    SNOMED
    3127006
    UMLS CUI [6,1]
    C1515119 (Systemic Therapy)
    UMLS CUI [6,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    patients may have received prior radiation therapy. radiation therapy must have been completed at least 30 days before registration.
    Beskrivning

    Therapeutic radiology procedure Completed

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [1,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    patients may have received prior surgery. prior surgery must have been completed at least 30 days before registration.
    Beskrivning

    Operative Surgical Procedure Completed

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [1,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    patients must have a zubrod performance status of 0-2.
    Beskrivning

    Zubrod Performance Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3714786 (Zubrod Performance Status)
    pregnant or nursing women are not eligible to participate in this trial because the safe use of these drugs in pregnancy have not been established. urine pregnancy test must be done prior to the study.
    Beskrivning

    Pregnancy | Breast Feeding | Urine pregnancy test

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [3]
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    patient must not have known allergic reaction to sulfonamides
    Beskrivning

    Allergic Reaction Sulfonamides

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304 (Allergic Reaction)
    SNOMED
    419076005
    UMLS CUI [1,2]
    C0038760 (Sulfonamides)
    SNOMED
    763875007
    patient must not have known allergic or other adverse reaction to celecoxib
    Beskrivning

    Allergic Reaction celecoxib | Adverse reactions celecoxib

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304 (Allergic Reaction)
    SNOMED
    419076005
    UMLS CUI [1,2]
    C0538927 (celecoxib)
    SNOMED
    370187009
    UMLS CUI [2,1]
    C0559546 (Adverse reactions)
    SNOMED
    281647001
    UMLS CUI [2,2]
    C0538927 (celecoxib)
    SNOMED
    370187009
    patient must not have persistent peripheral neuropathy
    Beskrivning

    Peripheral Neuropathy persistent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0031117 (Peripheral Neuropathy)
    UMLS CUI [1,2]
    C0205322 (Persistent)
    patient must not have known hypersensitivity reactions to 5-fu or platinum
    Beskrivning

    Hypersensitivity Fluorouracil | Hypersensitivity Platinum

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0016360 (fluorouracil)
    SNOMED
    3127006
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0206135 (Platinum Compounds, Inorganic)
    patient must not have active gastric/duodenal bleeding
    Beskrivning

    Gastric hemorrhage | Duodenal hemorrhage

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0235325 (Gastric hemorrhage)
    SNOMED
    61401005
    UMLS CUI [2]
    C0521595 (Duodenal hemorrhage)
    SNOMED
    95533003
    patient must not have had a sensitivity reaction to aspirin or other nsaids [experiencing asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids]
    Beskrivning

    Hypersensitivity Aspirin | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Asthma | Urticaria | Allergic Reaction Aspirin | Allergic Reaction Anti-Inflammatory Agents, Non-Steroidal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0004057 (aspirin)
    SNOMED
    7947003
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0003211 (Anti-Inflammatory Agents, Non-Steroidal)
    SNOMED
    16403005
    UMLS CUI [3]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [4]
    C0042109 (Urticaria)
    SNOMED
    247472004
    LOINC
    LA20642-7
    UMLS CUI [5,1]
    C1527304 (Allergic Reaction)
    SNOMED
    419076005
    UMLS CUI [5,2]
    C0004057 (aspirin)
    SNOMED
    7947003
    UMLS CUI [6,1]
    C1527304 (Allergic Reaction)
    SNOMED
    419076005
    UMLS CUI [6,2]
    C0003211 (Anti-Inflammatory Agents, Non-Steroidal)
    SNOMED
    16403005

    Similar models

    Eligibility Gastric Carcinoma NCT00256321

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Stomach Carcinoma unresectable | recurrent gastric cancer | Stomach Carcinoma Metastatic | Gastrooesophageal cancer unresectable | Gastrooesophageal cancer Recurrent | Gastrooesophageal cancer Metastatic | Gastric lymphoma | Gastrointestinal Stromal Tumors | Unstained Specimen Paraffin Embedding | COX-2 Expression Analysis
    Item
    patient must have histologically proven, pathologically verified and surgically incurable(unresectable, recurrent, or metastatic) gastric/gastroesophageal junction carcinoma. gastric lymphoma and gastrointestinal stromal tumor(gist) are ineligible for this study. at least 6 unstained paraffin-embedded pathologic specimen slides will be required for the cox-2 expression assays.
    boolean
    C0699791 (UMLS CUI [1,1])
    C1519810 (UMLS CUI [1,2])
    C0278502 (UMLS CUI [2])
    C0699791 (UMLS CUI [3,1])
    C0036525 (UMLS CUI [3,2])
    C1112160 (UMLS CUI [4,1])
    C1519810 (UMLS CUI [4,2])
    C1112160 (UMLS CUI [5,1])
    C2945760 (UMLS CUI [5,2])
    C1112160 (UMLS CUI [6,1])
    C0036525 (UMLS CUI [6,2])
    C0349532 (UMLS CUI [7])
    C0238198 (UMLS CUI [8])
    C1883469 (UMLS CUI [9,1])
    C0085185 (UMLS CUI [9,2])
    C2827630 (UMLS CUI [10])
    2-Dimensional Measurable Disease | Physical Examination | X-Ray Computed Tomography | Radionuclide Imaging | Plain x-ray
    Item
    patient must have bidimensionally measurable disease as defined in section 10.1a. all measurable lesions must be assessed (by physical examination, ct scan, radionuclide scan or plain x-ray) within 30 days prior to registration. the patient's disease status must be completely assessed and reported.
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    C0031809 (UMLS CUI [2])
    C0040405 (UMLS CUI [3])
    C0034606 (UMLS CUI [4])
    C1306645 (UMLS CUI [5])
    CT of abdomen | Chest CT
    Item
    all patients must undergo a ct of abdomen and chest within 30 days prior to registration.
    boolean
    C0412620 (UMLS CUI [1])
    C0202823 (UMLS CUI [2])
    Metastatic malignant neoplasm to brain | brain ct | brain MRI | Neurologic Symptoms | Secondary malignant neoplasm of lung | Radiography | Brain MRI W contrast IV
    Item
    patients with brain metastases are not eligible for this study. it is not mandatory to obtain brain ct or mri on all patients. however, patients who exhibit neurological symptoms or have pulmonary metastases on radiographic studies must obtain brain ct w/ iv contrast or mri prior to registration to ascertain the presence of brain metastasis.
    boolean
    C0220650 (UMLS CUI [1])
    C0412585 (UMLS CUI [2])
    C0412675 (UMLS CUI [3])
    C0235031 (UMLS CUI [4])
    C0153676 (UMLS CUI [5])
    C0034571 (UMLS CUI [6])
    C0881826 (UMLS CUI [7])
    capecitabine | oxaliplatin | Cisplatin | Carboplatin | Fluorouracil | systemic therapy Completed
    Item
    patients must not have received capecitabine or oxaliplatin. prior use of cisplatin, carboplatin, 5-fu are permitted. prior systemic therapy must have been completed at least 30 days before registration.
    boolean
    C0671970 (UMLS CUI [1])
    C0069717 (UMLS CUI [2])
    C0008838 (UMLS CUI [3])
    C0079083 (UMLS CUI [4])
    C0016360 (UMLS CUI [5])
    C1515119 (UMLS CUI [6,1])
    C0205197 (UMLS CUI [6,2])
    Therapeutic radiology procedure Completed
    Item
    patients may have received prior radiation therapy. radiation therapy must have been completed at least 30 days before registration.
    boolean
    C1522449 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Operative Surgical Procedure Completed
    Item
    patients may have received prior surgery. prior surgery must have been completed at least 30 days before registration.
    boolean
    C0543467 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Zubrod Performance Status
    Item
    patients must have a zubrod performance status of 0-2.
    boolean
    C3714786 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Urine pregnancy test
    Item
    pregnant or nursing women are not eligible to participate in this trial because the safe use of these drugs in pregnancy have not been established. urine pregnancy test must be done prior to the study.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0430056 (UMLS CUI [3])
    Allergic Reaction Sulfonamides
    Item
    patient must not have known allergic reaction to sulfonamides
    boolean
    C1527304 (UMLS CUI [1,1])
    C0038760 (UMLS CUI [1,2])
    Allergic Reaction celecoxib | Adverse reactions celecoxib
    Item
    patient must not have known allergic or other adverse reaction to celecoxib
    boolean
    C1527304 (UMLS CUI [1,1])
    C0538927 (UMLS CUI [1,2])
    C0559546 (UMLS CUI [2,1])
    C0538927 (UMLS CUI [2,2])
    Peripheral Neuropathy persistent
    Item
    patient must not have persistent peripheral neuropathy
    boolean
    C0031117 (UMLS CUI [1,1])
    C0205322 (UMLS CUI [1,2])
    Hypersensitivity Fluorouracil | Hypersensitivity Platinum
    Item
    patient must not have known hypersensitivity reactions to 5-fu or platinum
    boolean
    C0020517 (UMLS CUI [1,1])
    C0016360 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0206135 (UMLS CUI [2,2])
    Gastric hemorrhage | Duodenal hemorrhage
    Item
    patient must not have active gastric/duodenal bleeding
    boolean
    C0235325 (UMLS CUI [1])
    C0521595 (UMLS CUI [2])
    Hypersensitivity Aspirin | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Asthma | Urticaria | Allergic Reaction Aspirin | Allergic Reaction Anti-Inflammatory Agents, Non-Steroidal
    Item
    patient must not have had a sensitivity reaction to aspirin or other nsaids [experiencing asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids]
    boolean
    C0020517 (UMLS CUI [1,1])
    C0004057 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0003211 (UMLS CUI [2,2])
    C0004096 (UMLS CUI [3])
    C0042109 (UMLS CUI [4])
    C1527304 (UMLS CUI [5,1])
    C0004057 (UMLS CUI [5,2])
    C1527304 (UMLS CUI [6,1])
    C0003211 (UMLS CUI [6,2])

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