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ID

18507

Description

Trial of Pemetrexed or Pemetrexed With Gemcitabine for Patients With Advanced Lung Cancer Who Are Not Eligible for Platinum-Based Chemotherapy and Have Not Previously Been Treated With Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00489983

Link

https://clinicaltrials.gov/show/NCT00489983

Keywords

  1. 11/8/16 11/8/16 -
  2. 11/9/16 11/9/16 -
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November 9, 2016

DOI

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Creative Commons BY 4.0

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    Eligibility Non-Small Cell Lung Cancer NCT00489983

    Eligibility Non-Small Cell Lung Cancer NCT00489983

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically or cytologically confirmed nsclc not amenable to surgery or radiotherapy of curative intent
    Description

    Non-Small Cell Lung Carcinoma Amenable Operative Surgical Procedure Curative intent | Non-Small Cell Lung Carcinoma Amenable Therapeutic radiology procedure Curative intent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007131
    UMLS CUI [1,2]
    C3900053
    UMLS CUI [1,3]
    C0543467
    UMLS CUI [1,4]
    C1276305
    UMLS CUI [2,1]
    C0007131
    UMLS CUI [2,2]
    C3900053
    UMLS CUI [2,3]
    C1522449
    UMLS CUI [2,4]
    C1276305
    locally advanced or metastatic stage iiib (with n3 supraclavicular or t4 for pleural effusion) or iv nsclc
    Description

    Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | TNM clinical staging | Pleural effusion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007131
    UMLS CUI [1,2]
    C0205179
    UMLS CUI [1,3]
    C1517927
    UMLS CUI [2]
    C0278987
    UMLS CUI [3]
    C3258246
    UMLS CUI [4]
    C0032227
    no prior chemotherapy
    Description

    Prior Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514457
    measurable disease according to response evaluation criteria in solid tumors (recist) criteria (therasse et al. 2000)
    Description

    Measurable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    men and women greater than or equal to 70 years of age or patients who, in the investigator’s opinion, are not eligible for platinum-based chemotherapy
    Description

    Age | Chemotherapy Platinum-Based Patient not eligible

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C1514162
    UMLS CUI [2,3]
    C3242266
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
    Description

    Non-Prescription Drugs Indication Any

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013231
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C1552551
    have symptomatic brain metastases
    Description

    Metastatic malignant neoplasm to brain Symptomatic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650
    UMLS CUI [1,2]
    C0231220
    have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
    Description

    Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Malignant Neoplasms Treated | Recurrence | melanoma | Breast Carcinoma | Renal Cell Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0851140
    UMLS CUI [3,1]
    C0007117
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [4,1]
    C0006826
    UMLS CUI [4,2]
    C1522326
    UMLS CUI [5]
    C2825055
    UMLS CUI [6]
    C0025202
    UMLS CUI [7]
    C0678222
    UMLS CUI [8]
    C0007134
    are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
    Description

    Therapeutic procedure Interrupt Unable | Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Naproxen | Piroxicam | Diflunisal | nabumetone | pemetrexed Dose

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0443239
    UMLS CUI [1,3]
    C1299582
    UMLS CUI [2]
    C0004057
    UMLS CUI [3]
    C0003211
    UMLS CUI [4]
    C0027396
    UMLS CUI [5]
    C0031990
    UMLS CUI [6]
    C0012228
    UMLS CUI [7]
    C0068334
    UMLS CUI [8,1]
    C0210657
    UMLS CUI [8,2]
    C0178602
    are unable or unwilling to take steroids
    Description

    Steroids Intake Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038317
    UMLS CUI [1,2]
    C1512806
    UMLS CUI [1,3]
    C0558080
    are unable or unwilling to take folic acid or vitamin b12 supplementation
    Description

    Folate intake Unwilling | Vitamin B 12 supplementation Intake Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0564428
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [2,1]
    C0042845
    UMLS CUI [2,2]
    C0302837
    UMLS CUI [2,3]
    C1512806
    UMLS CUI [2,4]
    C0558080
    have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
    Description

    Ascites | Pleural effusion | Physical Examination | Drainage Unsuccessful

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003962
    UMLS CUI [2]
    C0032227
    UMLS CUI [3]
    C0031809
    UMLS CUI [4,1]
    C0013103
    UMLS CUI [4,2]
    C1272705
    have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:
    Description

    Comorbidity Investigator criteria | Medical condition Investigator criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0008961
    UMLS CUI [1,3]
    C0243161
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0008961
    UMLS CUI [2,3]
    C0243161
    congestive heart failure or angina pectoris, except if it is medically controlled
    Description

    Congestive heart failure | Angina Pectoris | Congestive heart failure Controlled Medical | Angina Pectoris Controlled Medical

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    UMLS CUI [2]
    C0002962
    UMLS CUI [3,1]
    C0018802
    UMLS CUI [3,2]
    C2911690
    UMLS CUI [3,3]
    C0205476
    UMLS CUI [4,1]
    C0002962
    UMLS CUI [4,2]
    C2911690
    UMLS CUI [4,3]
    C0205476
    previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
    Description

    Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C1868885
    UMLS CUI [3]
    C0003811
    active infection requiring iv antibiotics
    Description

    Communicable Disease Requirement Intravenous antibiotic therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0559680
    active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
    Description

    Ulcer | Brittle diabetes | Medical contraindication Adrenal Cortex Hormones

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0041582
    UMLS CUI [2]
    C0342302
    UMLS CUI [3,1]
    C1301624
    UMLS CUI [3,2]
    C0001617
    superior vena cava syndrome
    Description

    Superior Vena Cava Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038833

    Similar models

    Eligibility Non-Small Cell Lung Cancer NCT00489983

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Small Cell Lung Carcinoma Amenable Operative Surgical Procedure Curative intent | Non-Small Cell Lung Carcinoma Amenable Therapeutic radiology procedure Curative intent
    Item
    histologically or cytologically confirmed nsclc not amenable to surgery or radiotherapy of curative intent
    boolean
    C0007131 (UMLS CUI [1,1])
    C3900053 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    C1276305 (UMLS CUI [1,4])
    C0007131 (UMLS CUI [2,1])
    C3900053 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [2,3])
    C1276305 (UMLS CUI [2,4])
    Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | TNM clinical staging | Pleural effusion
    Item
    locally advanced or metastatic stage iiib (with n3 supraclavicular or t4 for pleural effusion) or iv nsclc
    boolean
    C0007131 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C1517927 (UMLS CUI [1,3])
    C0278987 (UMLS CUI [2])
    C3258246 (UMLS CUI [3])
    C0032227 (UMLS CUI [4])
    Prior Chemotherapy
    Item
    no prior chemotherapy
    boolean
    C1514457 (UMLS CUI [1])
    Measurable Disease
    Item
    measurable disease according to response evaluation criteria in solid tumors (recist) criteria (therasse et al. 2000)
    boolean
    C1513041 (UMLS CUI [1])
    Age | Chemotherapy Platinum-Based Patient not eligible
    Item
    men and women greater than or equal to 70 years of age or patients who, in the investigator’s opinion, are not eligible for platinum-based chemotherapy
    boolean
    C0001779 (UMLS CUI [1])
    C0392920 (UMLS CUI [2,1])
    C1514162 (UMLS CUI [2,2])
    C3242266 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Non-Prescription Drugs Indication Any
    Item
    have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
    boolean
    C0013231 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C1552551 (UMLS CUI [1,3])
    Metastatic malignant neoplasm to brain Symptomatic
    Item
    have symptomatic brain metastases
    boolean
    C0220650 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Malignant Neoplasms Treated | Recurrence | melanoma | Breast Carcinoma | Renal Cell Carcinoma
    Item
    have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
    boolean
    C0006826 (UMLS CUI [1])
    C0851140 (UMLS CUI [2])
    C0007117 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0006826 (UMLS CUI [4,1])
    C1522326 (UMLS CUI [4,2])
    C2825055 (UMLS CUI [5])
    C0025202 (UMLS CUI [6])
    C0678222 (UMLS CUI [7])
    C0007134 (UMLS CUI [8])
    Therapeutic procedure Interrupt Unable | Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Naproxen | Piroxicam | Diflunisal | nabumetone | pemetrexed Dose
    Item
    are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
    boolean
    C0087111 (UMLS CUI [1,1])
    C0443239 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
    C0004057 (UMLS CUI [2])
    C0003211 (UMLS CUI [3])
    C0027396 (UMLS CUI [4])
    C0031990 (UMLS CUI [5])
    C0012228 (UMLS CUI [6])
    C0068334 (UMLS CUI [7])
    C0210657 (UMLS CUI [8,1])
    C0178602 (UMLS CUI [8,2])
    Steroids Intake Unwilling
    Item
    are unable or unwilling to take steroids
    boolean
    C0038317 (UMLS CUI [1,1])
    C1512806 (UMLS CUI [1,2])
    C0558080 (UMLS CUI [1,3])
    Folate intake Unwilling | Vitamin B 12 supplementation Intake Unwilling
    Item
    are unable or unwilling to take folic acid or vitamin b12 supplementation
    boolean
    C0564428 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0042845 (UMLS CUI [2,1])
    C0302837 (UMLS CUI [2,2])
    C1512806 (UMLS CUI [2,3])
    C0558080 (UMLS CUI [2,4])
    Ascites | Pleural effusion | Physical Examination | Drainage Unsuccessful
    Item
    have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
    boolean
    C0003962 (UMLS CUI [1])
    C0032227 (UMLS CUI [2])
    C0031809 (UMLS CUI [3])
    C0013103 (UMLS CUI [4,1])
    C1272705 (UMLS CUI [4,2])
    Comorbidity Investigator criteria | Medical condition Investigator criteria
    Item
    have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:
    boolean
    C0009488 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    C0243161 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C0008961 (UMLS CUI [2,2])
    C0243161 (UMLS CUI [2,3])
    Congestive heart failure | Angina Pectoris | Congestive heart failure Controlled Medical | Angina Pectoris Controlled Medical
    Item
    congestive heart failure or angina pectoris, except if it is medically controlled
    boolean
    C0018802 (UMLS CUI [1])
    C0002962 (UMLS CUI [2])
    C0018802 (UMLS CUI [3,1])
    C2911690 (UMLS CUI [3,2])
    C0205476 (UMLS CUI [3,3])
    C0002962 (UMLS CUI [4,1])
    C2911690 (UMLS CUI [4,2])
    C0205476 (UMLS CUI [4,3])
    Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia
    Item
    previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
    boolean
    C0027051 (UMLS CUI [1])
    C1868885 (UMLS CUI [2])
    C0003811 (UMLS CUI [3])
    Communicable Disease Requirement Intravenous antibiotic therapy
    Item
    active infection requiring iv antibiotics
    boolean
    C0009450 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0559680 (UMLS CUI [1,3])
    Ulcer | Brittle diabetes | Medical contraindication Adrenal Cortex Hormones
    Item
    active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
    boolean
    C0041582 (UMLS CUI [1])
    C0342302 (UMLS CUI [2])
    C1301624 (UMLS CUI [3,1])
    C0001617 (UMLS CUI [3,2])
    Superior Vena Cava Syndrome
    Item
    superior vena cava syndrome
    boolean
    C0038833 (UMLS CUI [1])

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