ID

42252

Descrição

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

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Versões (1)
  1. 20/04/2021 20/04/2021 -
Titular dos direitos

GlaxoSmithKline

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20 de abril de 2021

DOI

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Creative Commons BY 4.0
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    Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

    Inglês

    Eligibility Criteria

    1 Formulários  
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Administrative
    Descrição

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Descrição

    Patient Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2986440
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    1. Written informed consent.
    Descrição

    1. Written informed consent.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. Age at least 18 years old.
    Descrição

    2. Age at least 18 years old.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
    Descrição

    3. Patient has a histologically proven ED SCLC (See protocol Appendix F).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0149925
    UMLS CUI [1,2]
    C0231449
    4. Patient has had no prior chemotherapy or immunotherapy.
    Descrição

    4. Patient has had no prior chemotherapy or immunotherapy.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0021083
    5. Patient has a presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion) defined by diagnostic studies including CT or MRI scan, chest X-ray or physical examination.
    Descrição

    Measurable disease on CT or MRI scan must have one diameter >= 1 cm and one diameter >= 2 cm Measurable disease on chest X-ray must have both diameters >=2 cm. Palpable tumor masses that cannot be evaluated radiologically must have two diameters >= 2 cm. A measurable skin lesion must have at least one diameter >= 1 cm and it's presence must be evaluated by a photograph.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1513040
    UMLS CUI [1,3]
    C1705052
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C1522602
    UMLS CUI [3]
    C0040405
    UMLS CUI [4]
    C0024485
    UMLS CUI [5]
    C0031809
    6. It has been at least 3 weeks since any previous surgery.
    Descrição

    6. It has been at least 3 weeks since any previous surgery (a lesser period is acceptable if deemed in the best interest of the patient).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0205156
    7. It has been at least 24 hours since any palliative radiotherapy and the extent and site of radiotherapy fields are such that marked bone marrow suppression is not expected.
    Descrição

    Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects. Permanent and stable side effects or changes are acceptable.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3898008
    UMLS CUI [2]
    C1522449
    UMLS CUI [3]
    C0280962
    8. Patient has adequate bone marrow reserve, hepatic and renal function
    Descrição

    - haemoglobin >= 9.0 g/dL (after transfusion if needed) - WBC >= 3.5 x 10^9/L - neutrophils >= 1.5 x 10^9/L - platelets >= 100 x 10^9/L - creatinine <=1.5 mg/dL (133 micromol/L) - creatinine clearance >= 60 mL/min calculated using the Cockcroft Gault formula - serum bilirubin <= 2.0 mg/dL (34 micromol/L) - SGOT/AST, SGPT/ALT, and Alkaline Phosphatase <= 2 times the upper limit of normal if liver metastases cannot be visualised by abdominal CT or MRI scan; or <= 5 times the upper limit of normal if liver metastases are present.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C0232741
    9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
    Descrição

    9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    10. Patient has a predicted life expectancy of at least 3 months at screening.
    Descrição

    10. Patient has a predicted life expectancy of at least 3 months at screening.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    UMLS CUI [2]
    C0220908
    11. Patient is not of reproductive potential, or if the patient is of reproductive potential the patient agrees to practice an effective method of contraception.
    Descrição

    11. Patient is not of reproductive potential, or if the patient is of reproductive potential the patient agrees to practice an effective method of contraception.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0015895
    UMLS CUI [2]
    C0700589
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    1. Patient is female and is pregnant or lactating.
    Descrição

    1. Patient is female and is pregnant or lactating.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
    Descrição

    2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2]
    C0700589
    3. Patient has an uncontrolled infection.
    Descrição

    3. Patient has an uncontrolled infection.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    4. Patient has previous or concomitant malignancies at other sites within the last 5 years excepting basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix or stage A low grade prostate cancer.
    Descrição

    4. Patient has previous or concomitant malignancies at other sites within the last 5 years excepting basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix or stage A low grade prostate cancer.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1515974
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0007117
    UMLS CUI [4]
    C0007137
    UMLS CUI [5]
    C0851140
    UMLS CUI [6]
    C0280280
    5. Patient has only undimensionally measurable or evaluable disease.
    Descrição

    5. Patient has only undimensionally measurable or evaluable disease.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2]
    C1516986
    6. Patient has clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
    Descrição

    A patient with brain and/ or leptomeningeal metastases on CT or MRI scan may be included only if he/ she is asymptomatic on neurological exam and is not receiving corticosteroid therapy to control symptoms)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0037088
    UMLS CUI [2]
    C0220650
    UMLS CUI [3]
    C1704231
    UMLS CUI [4]
    C0040405
    UMLS CUI [5]
    C0024485
    7. Patient has concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
    Descrição

    7. Patient has concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0006826
    UMLS CUI [2,2]
    C0439849
    UMLS CUI [3]
    C1321605
    UMLS CUI [4,1]
    C0205403
    UMLS CUI [4,2]
    C0035647
    UMLS CUI [5,1]
    C0023671
    UMLS CUI [5,2]
    C0547047
    8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
    Descrição

    8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0304229
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C0332152
    9. Patient has received other chemotherapy or immunotherapy, or concurrent radiotherapy, for the treatment of SCLC.
    Descrição

    Radiotherapy may be given concomitantly for the palliative control of bone pain, however not all measurable or evaluable lesions should be included in the irradiated field.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3665472
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2,1]
    C0021083
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0149925
    10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
    Descrição

    10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C2347662
    UMLS CUI [2]
    C0018802
    UMLS CUI [3,1]
    C0003811
    UMLS CUI [3,2]
    C0087111
    UMLS CUI [4]
    C0027051
    11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
    Descrição

    11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0013227
    UMLS CUI [3]
    C1301624
    Inclusion/ Exclusion
    Descrição

    Inclusion/ Exclusion

    Alias
    UMLS CUI-1
    C1512693
    UMLS CUI-2
    C0680251
    I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
    Descrição

    I have assessed the patient and checked the inclusion/exclusion criteria and the patient:

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    Investigator's Signature
    Descrição

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's Signature
    Descrição

    Investigator's Signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's Signature Date
    Descrição

    Investigator's Signature Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Eligibility Criteria

    1 Formulários
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    1. Written informed consent.
    Item
    1. Written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    2. Age at least 18 years old.
    Item
    2. Age at least 18 years old.
    boolean
    C0001779 (UMLS CUI [1])
    3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
    Item
    3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
    boolean
    C0149925 (UMLS CUI [1,1])
    C0231449 (UMLS CUI [1,2])
    4. Patient has had no prior chemotherapy or immunotherapy.
    Item
    4. Patient has had no prior chemotherapy or immunotherapy.
    boolean
    C0392920 (UMLS CUI [1])
    C0021083 (UMLS CUI [2])
    5. Patient has a presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion) defined by diagnostic studies including CT or MRI scan, chest X-ray or physical examination.
    Item
    5. Patient has a presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion) defined by diagnostic studies including CT or MRI scan, chest X-ray or physical examination.
    boolean
    C0221198 (UMLS CUI [1,1])
    C1513040 (UMLS CUI [1,2])
    C1705052 (UMLS CUI [1,3])
    C0221198 (UMLS CUI [2,1])
    C1522602 (UMLS CUI [2,2])
    C0040405 (UMLS CUI [3])
    C0024485 (UMLS CUI [4])
    C0031809 (UMLS CUI [5])
    6. It has been at least 3 weeks since any previous surgery (a lesser period is acceptable if deemed in the best interest of the patient).
    Item
    6. It has been at least 3 weeks since any previous surgery.
    boolean
    C0543467 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    7. It has been at least 24 hours since any palliative radiotherapy and the extent and site of radiotherapy fields are such that marked bone marrow suppression is not expected.
    Item
    7. It has been at least 24 hours since any palliative radiotherapy and the extent and site of radiotherapy fields are such that marked bone marrow suppression is not expected.
    boolean
    C3898008 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    C0280962 (UMLS CUI [3])
    8. Patient has adequate bone marrow reserve, hepatic and renal function
    Item
    8. Patient has adequate bone marrow reserve, hepatic and renal function
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0232804 (UMLS CUI [2])
    C0232741 (UMLS CUI [3])
    9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
    Item
    9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
    boolean
    C1520224 (UMLS CUI [1])
    10. Patient has a predicted life expectancy of at least 3 months at screening.
    Item
    10. Patient has a predicted life expectancy of at least 3 months at screening.
    boolean
    C0023671 (UMLS CUI [1])
    C0220908 (UMLS CUI [2])
    11. Patient is not of reproductive potential, or if the patient is of reproductive potential the patient agrees to practice an effective method of contraception.
    Item
    11. Patient is not of reproductive potential, or if the patient is of reproductive potential the patient agrees to practice an effective method of contraception.
    boolean
    C0015895 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    1. Patient is female and is pregnant or lactating.
    Item
    1. Patient is female and is pregnant or lactating.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
    Item
    2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
    boolean
    C3831118 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    3. Patient has an uncontrolled infection.
    Item
    3. Patient has an uncontrolled infection.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    4. Patient has previous or concomitant malignancies at other sites within the last 5 years excepting basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix or stage A low grade prostate cancer.
    Item
    4. Patient has previous or concomitant malignancies at other sites within the last 5 years excepting basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix or stage A low grade prostate cancer.
    boolean
    C0006826 (UMLS CUI [1])
    C1515974 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0007117 (UMLS CUI [3])
    C0007137 (UMLS CUI [4])
    C0851140 (UMLS CUI [5])
    C0280280 (UMLS CUI [6])
    5. Patient has only undimensionally measurable or evaluable disease.
    Item
    5. Patient has only undimensionally measurable or evaluable disease.
    boolean
    C1513041 (UMLS CUI [1])
    C1516986 (UMLS CUI [2])
    6. Patient has clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
    Item
    6. Patient has clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
    boolean
    C0037088 (UMLS CUI [1])
    C0220650 (UMLS CUI [2])
    C1704231 (UMLS CUI [3])
    C0040405 (UMLS CUI [4])
    C0024485 (UMLS CUI [5])
    7. Patient has concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
    Item
    7. Patient has concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [2,1])
    C0439849 (UMLS CUI [2,2])
    C1321605 (UMLS CUI [3])
    C0205403 (UMLS CUI [4,1])
    C0035647 (UMLS CUI [4,2])
    C0023671 (UMLS CUI [5,1])
    C0547047 (UMLS CUI [5,2])
    8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
    Item
    8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
    boolean
    C0304229 (UMLS CUI [1])
    C0008976 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    9. Patient has received other chemotherapy or immunotherapy, or concurrent radiotherapy, for the treatment of SCLC.
    Item
    9. Patient has received other chemotherapy or immunotherapy, or concurrent radiotherapy, for the treatment of SCLC.
    boolean
    C3665472 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0021083 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0149925 (UMLS CUI [3])
    10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
    Item
    10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
    boolean
    C0018799 (UMLS CUI [1,1])
    C2347662 (UMLS CUI [1,2])
    C0018802 (UMLS CUI [2])
    C0003811 (UMLS CUI [3,1])
    C0087111 (UMLS CUI [3,2])
    C0027051 (UMLS CUI [4])
    11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
    Item
    11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    C1301624 (UMLS CUI [3])
    Item Group
    Inclusion/ Exclusion
    C1512693 (UMLS CUI-1)
    C0680251 (UMLS CUI-2)
    Item
    I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
    integer
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
    Code List
    I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
    CL Item
    Is eligible to participate in the study. (1)
    CL Item
    Is not eligible to participate in the study. (2)
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's Signature Date
    Item
    Investigator's Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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