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ID

18467

Beschreibung

A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00138658

Link

https://clinicaltrials.gov/show/NCT00138658

Stichworte

  1. 06.11.16 06.11.16 -
Hochgeladen am

6. November 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Non-small Cell Lung Cancer NCT00138658

    Eligibility Non-small Cell Lung Cancer NCT00138658

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients must have a histologically or cytologically confirmed diagnosis of nsclc and must not have had chemotherapy or biological therapy for their disease.
    Beschreibung

    Non-Small Cell Lung Carcinoma | Chemotherapy Disease | Biological Response Modifier Therapy Disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C0012634
    UMLS CUI [3,1]
    C0005527
    UMLS CUI [3,2]
    C0012634
    2. stage iiib (n3 and/or pleural or pericardial effusion) or iv disease that is not amenable to either surgery or radiation therapy of curative intent.
    Beschreibung

    TNM clinical staging | Pleural effusion disorder | Pericardial effusion | Disease Amenable Operative Surgical Procedures | Disease Amenable Therapeutic radiology procedure Curative intent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3258246
    UMLS CUI [2]
    C0032227
    UMLS CUI [3]
    C0031039
    UMLS CUI [4,1]
    C0012634
    UMLS CUI [4,2]
    C3900053
    UMLS CUI [4,3]
    C0543467
    UMLS CUI [5,1]
    C0012634
    UMLS CUI [5,2]
    C3900053
    UMLS CUI [5,3]
    C1522449
    UMLS CUI [5,4]
    C1276305
    3. life expectancy of ≥ 12 weeks
    Beschreibung

    Life Expectancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    4. if patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
    Beschreibung

    prior radiation therapy | Therapeutic radiology procedure Lesion | Lesion Use of Evaluating response to treatment | Lesion Increased size | Toxic effect Due to Therapeutic radiology procedure | Patient Recovered

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0279134
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0221198
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C1524063
    UMLS CUI [3,3]
    C0184781
    UMLS CUI [4,1]
    C0221198
    UMLS CUI [4,2]
    C0332509
    UMLS CUI [5,1]
    C0600688
    UMLS CUI [5,2]
    C0678226
    UMLS CUI [5,3]
    C1522449
    UMLS CUI [6,1]
    C0030705
    UMLS CUI [6,2]
    C0521108
    5. radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
    Beschreibung

    Therapeutic radiology procedure Completed Lesion Quantity | Evaluating response to treatment | Therapeutic radiology procedure Completed Site

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [1,3]
    C0221198
    UMLS CUI [1,4]
    C1265611
    UMLS CUI [2]
    C0184781
    UMLS CUI [3,1]
    C1522449
    UMLS CUI [3,2]
    C0205197
    UMLS CUI [3,3]
    C1515974
    6. at least one unidimensionally measurable lesion meeting response evaluation criteria in solid tumors [recist] (at least 10 mm in longest diameter by spiral computed tomography [ct] scan, or at least 20 mm by standard techniques).
    Beschreibung

    Measurable Disease Linear Quantity | Measurable Disease Longest Diameter | Tomography, Spiral Computed | Measurement technique Standard

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C0205132
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [2,1]
    C1513041
    UMLS CUI [2,2]
    C0552406
    UMLS CUI [3]
    C0860888
    UMLS CUI [4,1]
    C0242485
    UMLS CUI [4,2]
    C1442989
    7. ecog status must be ≤ 1
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. prior chemotherapy or biological therapy (approved or experimental) for nsclc, including adjuvant and neoadjuvant treatment.
    Beschreibung

    Prior Chemotherapy Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Approved Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Investigational Non-Small Cell Lung Carcinoma | Adjuvant therapy Non-Small Cell Lung Carcinoma | Neoadjuvant Therapy Non-Small Cell Lung Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0007131
    UMLS CUI [2,1]
    C0005527
    UMLS CUI [2,2]
    C0205540
    UMLS CUI [2,3]
    C0007131
    UMLS CUI [3,1]
    C0005527
    UMLS CUI [3,2]
    C1517586
    UMLS CUI [3,3]
    C0007131
    UMLS CUI [4,1]
    C0677850
    UMLS CUI [4,2]
    C0007131
    UMLS CUI [5,1]
    C0600558
    UMLS CUI [5,2]
    C0007131
    2. presence of central nervous system (cns) metastases, unless the patient has completed successful local therapy for cns metastases, with the exception of leptomeningeal disease for which patients will be excluded. patients must be off corticosteroids for at least 21 days prior to starting treatment.
    Beschreibung

    CNS metastases | Local Therapy Completed CNS metastases | Leptomeningeal disease | Adrenal Cortex Hormones Discontinued

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    UMLS CUI [2,1]
    C1517925
    UMLS CUI [2,2]
    C0205197
    UMLS CUI [2,3]
    C0686377
    UMLS CUI [3]
    C3160796
    UMLS CUI [4,1]
    C0001617
    UMLS CUI [4,2]
    C1444662
    3. second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).
    Beschreibung

    Second Primary Cancer | Carcinoma in situ of uterine cervix | Skin carcinoma Treated | Malignant neoplasm of prostate Localized Clinical | Carcinoma of urinary bladder, superficial | Malignant Neoplasm Treated | Recurrence Evidence

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0751623
    UMLS CUI [2]
    C0851140
    UMLS CUI [3,1]
    C0699893
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [4,1]
    C0376358
    UMLS CUI [4,2]
    C0392752
    UMLS CUI [4,3]
    C0205210
    UMLS CUI [5]
    C1336527
    UMLS CUI [6,1]
    C0006826
    UMLS CUI [6,2]
    C1522326
    UMLS CUI [7,1]
    C2825055
    UMLS CUI [7,2]
    C3887511
    4. patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (this criteria is intended to exclude patients with stage iiib disease, as defined by the presence of n3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)
    Beschreibung

    Indication Combined Modality Therapy Curative intent | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | TNM clinical staging

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0009429
    UMLS CUI [1,3]
    C1276305
    UMLS CUI [2]
    C0392920
    UMLS CUI [3]
    C1522449
    UMLS CUI [4]
    C0543467
    UMLS CUI [5]
    C3258246

    Ähnliche Modelle

    Eligibility Non-small Cell Lung Cancer NCT00138658

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Small Cell Lung Carcinoma | Chemotherapy Disease | Biological Response Modifier Therapy Disease
    Item
    1. patients must have a histologically or cytologically confirmed diagnosis of nsclc and must not have had chemotherapy or biological therapy for their disease.
    boolean
    C0007131 (UMLS CUI [1])
    C0392920 (UMLS CUI [2,1])
    C0012634 (UMLS CUI [2,2])
    C0005527 (UMLS CUI [3,1])
    C0012634 (UMLS CUI [3,2])
    TNM clinical staging | Pleural effusion disorder | Pericardial effusion | Disease Amenable Operative Surgical Procedures | Disease Amenable Therapeutic radiology procedure Curative intent
    Item
    2. stage iiib (n3 and/or pleural or pericardial effusion) or iv disease that is not amenable to either surgery or radiation therapy of curative intent.
    boolean
    C3258246 (UMLS CUI [1])
    C0032227 (UMLS CUI [2])
    C0031039 (UMLS CUI [3])
    C0012634 (UMLS CUI [4,1])
    C3900053 (UMLS CUI [4,2])
    C0543467 (UMLS CUI [4,3])
    C0012634 (UMLS CUI [5,1])
    C3900053 (UMLS CUI [5,2])
    C1522449 (UMLS CUI [5,3])
    C1276305 (UMLS CUI [5,4])
    Life Expectancy
    Item
    3. life expectancy of ≥ 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    prior radiation therapy | Therapeutic radiology procedure Lesion | Lesion Use of Evaluating response to treatment | Lesion Increased size | Toxic effect Due to Therapeutic radiology procedure | Patient Recovered
    Item
    4. if patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
    boolean
    C0279134 (UMLS CUI [1])
    C1522449 (UMLS CUI [2,1])
    C0221198 (UMLS CUI [2,2])
    C0221198 (UMLS CUI [3,1])
    C1524063 (UMLS CUI [3,2])
    C0184781 (UMLS CUI [3,3])
    C0221198 (UMLS CUI [4,1])
    C0332509 (UMLS CUI [4,2])
    C0600688 (UMLS CUI [5,1])
    C0678226 (UMLS CUI [5,2])
    C1522449 (UMLS CUI [5,3])
    C0030705 (UMLS CUI [6,1])
    C0521108 (UMLS CUI [6,2])
    Therapeutic radiology procedure Completed Lesion Quantity | Evaluating response to treatment | Therapeutic radiology procedure Completed Site
    Item
    5. radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
    boolean
    C1522449 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [1,3])
    C1265611 (UMLS CUI [1,4])
    C0184781 (UMLS CUI [2])
    C1522449 (UMLS CUI [3,1])
    C0205197 (UMLS CUI [3,2])
    C1515974 (UMLS CUI [3,3])
    Measurable Disease Linear Quantity | Measurable Disease Longest Diameter | Tomography, Spiral Computed | Measurement technique Standard
    Item
    6. at least one unidimensionally measurable lesion meeting response evaluation criteria in solid tumors [recist] (at least 10 mm in longest diameter by spiral computed tomography [ct] scan, or at least 20 mm by standard techniques).
    boolean
    C1513041 (UMLS CUI [1,1])
    C0205132 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C1513041 (UMLS CUI [2,1])
    C0552406 (UMLS CUI [2,2])
    C0860888 (UMLS CUI [3])
    C0242485 (UMLS CUI [4,1])
    C1442989 (UMLS CUI [4,2])
    ECOG performance status
    Item
    7. ecog status must be ≤ 1
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Prior Chemotherapy Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Approved Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Investigational Non-Small Cell Lung Carcinoma | Adjuvant therapy Non-Small Cell Lung Carcinoma | Neoadjuvant Therapy Non-Small Cell Lung Carcinoma
    Item
    1. prior chemotherapy or biological therapy (approved or experimental) for nsclc, including adjuvant and neoadjuvant treatment.
    boolean
    C1514457 (UMLS CUI [1,1])
    C0007131 (UMLS CUI [1,2])
    C0005527 (UMLS CUI [2,1])
    C0205540 (UMLS CUI [2,2])
    C0007131 (UMLS CUI [2,3])
    C0005527 (UMLS CUI [3,1])
    C1517586 (UMLS CUI [3,2])
    C0007131 (UMLS CUI [3,3])
    C0677850 (UMLS CUI [4,1])
    C0007131 (UMLS CUI [4,2])
    C0600558 (UMLS CUI [5,1])
    C0007131 (UMLS CUI [5,2])
    CNS metastases | Local Therapy Completed CNS metastases | Leptomeningeal disease | Adrenal Cortex Hormones Discontinued
    Item
    2. presence of central nervous system (cns) metastases, unless the patient has completed successful local therapy for cns metastases, with the exception of leptomeningeal disease for which patients will be excluded. patients must be off corticosteroids for at least 21 days prior to starting treatment.
    boolean
    C0686377 (UMLS CUI [1])
    C1517925 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C0686377 (UMLS CUI [2,3])
    C3160796 (UMLS CUI [3])
    C0001617 (UMLS CUI [4,1])
    C1444662 (UMLS CUI [4,2])
    Second Primary Cancer | Carcinoma in situ of uterine cervix | Skin carcinoma Treated | Malignant neoplasm of prostate Localized Clinical | Carcinoma of urinary bladder, superficial | Malignant Neoplasm Treated | Recurrence Evidence
    Item
    3. second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).
    boolean
    C0751623 (UMLS CUI [1])
    C0851140 (UMLS CUI [2])
    C0699893 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0376358 (UMLS CUI [4,1])
    C0392752 (UMLS CUI [4,2])
    C0205210 (UMLS CUI [4,3])
    C1336527 (UMLS CUI [5])
    C0006826 (UMLS CUI [6,1])
    C1522326 (UMLS CUI [6,2])
    C2825055 (UMLS CUI [7,1])
    C3887511 (UMLS CUI [7,2])
    Indication Combined Modality Therapy Curative intent | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | TNM clinical staging
    Item
    4. patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (this criteria is intended to exclude patients with stage iiib disease, as defined by the presence of n3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)
    boolean
    C3146298 (UMLS CUI [1,1])
    C0009429 (UMLS CUI [1,2])
    C1276305 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    C0543467 (UMLS CUI [4])
    C3258246 (UMLS CUI [5])

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