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NCT00936936 · BASELINE

Baseline characteristics

High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors · Source last updated 2024-08-26

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

denoms
  1. counts
    1. group Id
      BG000
      value
      41
    2. group Id
      BG001
      value
      23
    3. group Id
      BG002
      value
      64
    units
    Participants
groups
  1. description
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    id
    BG000
    title
    Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
  2. description
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    id
    BG001
    title
    Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          61
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          59
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          31
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          64
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      41
    2. group Id
      BG001
      value
      23
    3. group Id
      BG002
      value
      64
    units
    Participants
groups
  1. description
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    id
    BG000
    title
    Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
  2. description
    First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
    id
    BG001
    title
    Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          61
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          59
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          31
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          64
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice