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NCT01602666 · FLOW

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Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors · Source last updated 2025-11-20

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

groups
  1. description
    Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
    id
    FG000
    title
    Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
  2. description
    Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
    id
    FG001
    title
    Stratum 2 Localized Germinoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        7
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      Refusal of further protocol therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Radiotherapy can't be initiated in 6 wks
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        137
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        113
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Induction Chemotherapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      In-evaluable for reduced dose(30.6 Gy)
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      type
      In-evaluable for reduced dose(18 Gy)
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      In-evaluable for RT dose (24Gy)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        113
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        0
      type
      Evaluable for Reduced Dose (30Gy)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        74
      type
      Evaluable for Reduced Dose (18 Gy)
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        16
      type
      Evaluable for RT Dose (24Gy)
    5. achievements
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        82
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Radiation Therapy on Protocol
pre Assignment Details
There were 111 patients enrolled in Stratum 1 with localized nongerminomatous germ cell tumors (NGGCT) and 151 patients enrolled in Stratum 2 with localized CNS Germinoma (Germinoma). Of these 107 in Stratum 1 and 137 in Stratum 2 were deemed eligible for the study. This report is limited to eligible subjects.
recruitment Details
Patients enrolled on the study from 6/27/2012 to 11/1/2016 on Stratum 1 and from 6/27/2012 to 10/26/2018 on Stratum 2
Complete source fields
groups
  1. description
    Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
    id
    FG000
    title
    Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
  2. description
    Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with \> 0.5 cm (suprasellar) or \> 1 cm (pineal) but =\< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
    id
    FG001
    title
    Stratum 2 Localized Germinoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        7
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      Refusal of further protocol therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Radiotherapy can't be initiated in 6 wks
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        137
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        113
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Induction Chemotherapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      In-evaluable for reduced dose(30.6 Gy)
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      type
      In-evaluable for reduced dose(18 Gy)
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      In-evaluable for RT dose (24Gy)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        113
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        0
      type
      Evaluable for Reduced Dose (30Gy)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        74
      type
      Evaluable for Reduced Dose (18 Gy)
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        16
      type
      Evaluable for RT Dose (24Gy)
    5. achievements
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        82
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Radiation Therapy on Protocol
pre Assignment Details
There were 111 patients enrolled in Stratum 1 with localized nongerminomatous germ cell tumors (NGGCT) and 151 patients enrolled in Stratum 2 with localized CNS Germinoma (Germinoma). Of these 107 in Stratum 1 and 137 in Stratum 2 were deemed eligible for the study. This report is limited to eligible subjects.
recruitment Details
Patients enrolled on the study from 6/27/2012 to 11/1/2016 on Stratum 1 and from 6/27/2012 to 10/26/2018 on Stratum 2

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Preserved source evidence · Not medical advice