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NCT01231906 · FLOW

Participant flow

Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma · Source last updated 2026-01-23

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

groups
  1. description
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
    id
    FG000
    title
    Arm A (Combination Chemotherapy)
  2. description
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
    id
    FG001
    title
    Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        68
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        24
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        3
      type
      Ineligible
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      No treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        319
      2. group Id
        FG001
        num Subjects
        323
      comment
      Eligible and began receiving protocol therapy
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        308
      2. group Id
        FG001
        num Subjects
        318
      type
      Received Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        198
      2. group Id
        FG001
        num Subjects
        222
      comment
      Completion of planned therapy with no event observed: disease progression, second malignant neoplasm (SMN), death regardless of cause
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        121
      2. group Id
        FG001
        num Subjects
        101
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
    id
    FG000
    title
    Arm A (Combination Chemotherapy)
  2. description
    INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
    id
    FG001
    title
    Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        68
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        24
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        3
      type
      Ineligible
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      No treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        319
      2. group Id
        FG001
        num Subjects
        323
      comment
      Eligible and began receiving protocol therapy
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        308
      2. group Id
        FG001
        num Subjects
        318
      type
      Received Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        198
      2. group Id
        FG001
        num Subjects
        222
      comment
      Completion of planned therapy with no event observed: disease progression, second malignant neoplasm (SMN), death regardless of cause
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        121
      2. group Id
        FG001
        num Subjects
        101
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice