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NCT02595424 · FLOW

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Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas · Source last updated 2026-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO
    id
    FG000
    title
    Arm A (Capecitabine, Temozolomide)
  2. description
    Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    FG001
    title
    Arm B (Cisplatin, Carboplatin, Etoposide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Alternative therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      type
      Never start protocol therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        32
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        29
      type
      Started protocol therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        35
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on November 6th, 2015 and closed to accrual on April 1st, 2021 with final accrual of 67 patients.
Complete source fields
groups
  1. description
    Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO
    id
    FG000
    title
    Arm A (Capecitabine, Temozolomide)
  2. description
    Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    FG001
    title
    Arm B (Cisplatin, Carboplatin, Etoposide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Alternative therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      type
      Never start protocol therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        32
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        29
      type
      Started protocol therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        35
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on November 6th, 2015 and closed to accrual on April 1st, 2021 with final accrual of 67 patients.

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Preserved source evidence · Not medical advice