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ID

37770

Description

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Keywords

Versions (2)
  1. 8/22/19 8/22/19 -
  2. 8/23/19 8/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

    English

    Screening - Significant Medical/ Surgical History and Physical Examination; History of Ovarian Cancer; Tumor Marker

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Description

    Center Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709561
    Patient ID
    Description

    Patient ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Significant Medical/ Surgical History and Physical Examination
    Description

    Significant Medical/ Surgical History and Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0489540
    UMLS CUI-3
    C0031809
    Is the patient suffering from or has she ever suffered from any significant medical or surgical condition not related to the study indication?
    Description

    If ”Yes“, please provide diagnosis below listing no more than one diagnosis per line.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543467
    UMLS CUI [2]
    C0012634
    UMLS CUI [3,1]
    C2603343
    UMLS CUI [3,2]
    C3146298
    UMLS CUI [3,3]
    C0439849
    Significant Medical/ Surgical History and Physical Examination
    Description

    Significant Medical/ Surgical History and Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0489540
    UMLS CUI-3
    C0031809
    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Date of Diagnosis
    Description

    Date of Diagnosis

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2316983
    Status of Disease
    Description

    Status of Disease

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0699749
    History of Ovarian Cancer
    Description

    History of Ovarian Cancer

    Alias
    UMLS CUI-1
    C0029925
    UMLS CUI-2
    C0262926
    Date of Original Diagnosis
    Description

    Date of Original Diagnosis

    Data type

    date

    Alias
    UMLS CUI [1]
    C2316983
    Date of Relapse
    Description

    Date of Relapse

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0035020
    UMLS CUI [1,2]
    C0011008
    Primary Tumor Diagnosis
    Description

    (please choose one)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0677930
    UMLS CUI [1,2]
    C0011900
    Please record the current TNM stage of the patient
    Description

    Please record the current TNM stage of the patient

    Data type

    text

    Alias
    UMLS CUI [1]
    C1302362
    FIGO Stage of current disease
    Description

    (please choose one) NOTE: Patient is ONL Y eligible if she is stage IIIB, IIIC or IV.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0450454
    Metastatic
    Description

    Metastatic

    Alias
    UMLS CUI-1
    C0027627
    Metastasis - Date of Diagnosis
    Description

    Metastasis - Date of Diagnosis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C0027627
    Metastasis - Site
    Description

    Metastasis - Site

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0807944
    If other site of metastasis, specify.
    Description

    If other site of metastasis, specify.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0807944
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Tumor Marker (CA-125) (7 days prior to Day 1)
    Description

    Tumor Marker (CA-125) (7 days prior to Day 1)

    Alias
    UMLS CUI-1
    C0474700
    UMLS CUI-2
    C0201549
    Sample Date
    Description

    Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    CA-125 Value
    Description

    CA-125 Value

    Data type

    integer

    Measurement units
    • U/mL
    Alias
    UMLS CUI [1]
    C0201549
    U/mL
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    Similar models

    Screening - Significant Medical/ Surgical History and Physical Examination; History of Ovarian Cancer; Tumor Marker

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1709561 (UMLS CUI [1])
    Patient ID
    Item
    Patient ID
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Significant Medical/ Surgical History and Physical Examination
    C0262926 (UMLS CUI-1)
    C0489540 (UMLS CUI-2)
    C0031809 (UMLS CUI-3)
    Is the patient suffering from or has she ever suffered from any significant medical or surgical condition not related to the study indication?
    Item
    Is the patient suffering from or has she ever suffered from any significant medical or surgical condition not related to the study indication?
    boolean
    C0543467 (UMLS CUI [1])
    C0012634 (UMLS CUI [2])
    C2603343 (UMLS CUI [3,1])
    C3146298 (UMLS CUI [3,2])
    C0439849 (UMLS CUI [3,3])
    Item Group
    Significant Medical/ Surgical History and Physical Examination
    C0262926 (UMLS CUI-1)
    C0489540 (UMLS CUI-2)
    C0031809 (UMLS CUI-3)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Date of Diagnosis
    Item
    Date of Diagnosis
    partialDate
    C2316983 (UMLS CUI [1])
    Item
    Status of Disease
    integer
    C0699749 (UMLS CUI [1])
    Status of Disease
    Code List
    Status of Disease
    CL Item
    Past (1)
    CL Item
    Current/ Active (2)
    Item Group
    History of Ovarian Cancer
    C0029925 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Date of Original Diagnosis
    Item
    Date of Original Diagnosis
    date
    C2316983 (UMLS CUI [1])
    Date of Relapse
    Item
    Date of Relapse
    date
    C0035020 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Primary Tumor Diagnosis
    integer
    C0677930 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Primary Tumor Diagnosis
    Code List
    Primary Tumor Diagnosis
    CL Item
    Epithelial ovarian carcinoma  (1)
    CL Item
    Primary peritoneal carcinoma  (2)
    CL Item
    Fallopian tube carcinoma  (3)
    CL Item
    Tumors of mixed mullerian origin (4)
    Please record the current TNM stage of the patient
    Item
    Please record the current TNM stage of the patient
    text
    C1302362 (UMLS CUI [1])
    Item
    FIGO Stage of current disease
    integer
    C0450454 (UMLS CUI [1])
    FIGO Stage of current disease
    Code List
    FIGO Stage of current disease
    CL Item
    IIIB Macroscopic peritoneal metastasis beyond pelvis 2 cm or less in greatest dimension.  (1)
    CL Item
    IIIC Peritoneal metastasis beyond pelvis more than 2 cm in greatest dimension and/or regional lymph node metastasis.  (2)
    CL Item
    IV Distant metastasis (excludes peritoneal metastasis). (3)
    Item Group
    Metastatic
    C0027627 (UMLS CUI-1)
    Metastasis - Date of Diagnosis
    Item
    Metastasis - Date of Diagnosis
    date
    C2316983 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    Item
    Metastasis - Site
    integer
    C0807944 (UMLS CUI [1])
    Metastasis - Site
    Code List
    Metastasis - Site
    CL Item
    Lymph Node  (1)
    CL Item
    Liver  (2)
    CL Item
    Other, Specify. (3)
    If other site of metastasis, specify.
    Item
    If other site of metastasis, specify.
    text
    C0807944 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Tumor Marker (CA-125) (7 days prior to Day 1)
    C0474700 (UMLS CUI-1)
    C0201549 (UMLS CUI-2)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    CA-125 Value
    Item
    CA-125 Value
    integer
    C0201549 (UMLS CUI [1])
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