Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00025259 · BASELINE

Baseline characteristics

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease · Source last updated 2017-04-12

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
      52
    2. group Id
      BG001
      value
      381
    3. group Id
      BG002
      value
      382
    4. group Id
      BG003
      value
      571
    5. group Id
      BG004
      value
      42
    6. group Id
      BG005
      value
      153
    7. group Id
      BG006
      value
      153
    8. group Id
      BG007
      value
      1734
    units
    Participants
groups
  1. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG000
    title
    Arm I (Patients Off-therapy Before Callback-Induction Only)
  2. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG001
    title
    Arm II (RER With CR [ABVE-PC, IFRT])
  3. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG002
    title
    Arm III (RER With CR [ABVE-PC])
  4. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG003
    title
    Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
  5. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG004
    title
    Arm V (RER With PD)
  6. description
    Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre
    id
    BG005
    title
    Arm VI (SER [DECA, ABVE-PC, IFRT])
  7. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG006
    title
    Arm VII (SER [ABVE-PC, IFRT])
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          363
        3. group Id
          BG002
          value
          369
        4. group Id
          BG003
          value
          540
        5. group Id
          BG004
          value
          40
        6. group Id
          BG005
          value
          143
        7. group Id
          BG006
          value
          148
        8. group Id
          BG007
          value
          1649
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          85
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          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
          lower Limit
          5
          upper Limit
          20
          value
          16
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          21
          value
          14
        3. group Id
          BG002
          lower Limit
          3
          upper Limit
          21
          value
          14
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          21
          value
          15
        5. group Id
          BG004
          lower Limit
          5
          upper Limit
          19
          value
          15
        6. group Id
          BG005
          lower Limit
          5
          upper Limit
          21
          value
          15
        7. group Id
          BG006
          lower Limit
          5
          upper Limit
          21
          value
          15
        8. group Id
          BG007
          lower Limit
          1
          upper Limit
          21
          value
          15
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          155
        4. group Id
          BG003
          value
          288
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          81
        7. group Id
          BG006
          value
          77
        8. group Id
          BG007
          value
          815
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          227
        4. group Id
          BG003
          value
          283
        5. group Id
          BG004
          value
          26
        6. group Id
          BG005
          value
          72
        7. group Id
          BG006
          value
          76
        8. group Id
          BG007
          value
          919
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          74
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          22
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          259
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          293
        3. group Id
          BG002
          value
          306
        4. group Id
          BG003
          value
          487
        5. group Id
          BG004
          value
          34
        6. group Id
          BG005
          value
          127
        7. group Id
          BG006
          value
          134
        8. group Id
          BG007
          value
          1425
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          50
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          50
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          6
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          67
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          194
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          290
        3. group Id
          BG002
          value
          297
        4. group Id
          BG003
          value
          444
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          122
        7. group Id
          BG006
          value
          124
        8. group Id
          BG007
          value
          1348
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          132
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
      title
      New Zealand
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          51
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          175
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          312
        4. group Id
          BG003
          value
          491
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          125
        7. group Id
          BG006
          value
          128
        8. group Id
          BG007
          value
          1469
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          6
      title
      Israel
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          40
      title
      Australia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Switzerland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Kuwait
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      France
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          22
      title
      Netherlands
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          13
      title
      Puerto Rico
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Bermuda
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      French Polynesia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      52
    2. group Id
      BG001
      value
      381
    3. group Id
      BG002
      value
      382
    4. group Id
      BG003
      value
      571
    5. group Id
      BG004
      value
      42
    6. group Id
      BG005
      value
      153
    7. group Id
      BG006
      value
      153
    8. group Id
      BG007
      value
      1734
    units
    Participants
groups
  1. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG000
    title
    Arm I (Patients Off-therapy Before Callback-Induction Only)
  2. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG001
    title
    Arm II (RER With CR [ABVE-PC, IFRT])
  3. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG002
    title
    Arm III (RER With CR [ABVE-PC])
  4. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG003
    title
    Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
  5. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG004
    title
    Arm V (RER With PD)
  6. description
    Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre
    id
    BG005
    title
    Arm VI (SER [DECA, ABVE-PC, IFRT])
  7. description
    Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV
    id
    BG006
    title
    Arm VII (SER [ABVE-PC, IFRT])
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          363
        3. group Id
          BG002
          value
          369
        4. group Id
          BG003
          value
          540
        5. group Id
          BG004
          value
          40
        6. group Id
          BG005
          value
          143
        7. group Id
          BG006
          value
          148
        8. group Id
          BG007
          value
          1649
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          85
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          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
          lower Limit
          5
          upper Limit
          20
          value
          16
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          21
          value
          14
        3. group Id
          BG002
          lower Limit
          3
          upper Limit
          21
          value
          14
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          21
          value
          15
        5. group Id
          BG004
          lower Limit
          5
          upper Limit
          19
          value
          15
        6. group Id
          BG005
          lower Limit
          5
          upper Limit
          21
          value
          15
        7. group Id
          BG006
          lower Limit
          5
          upper Limit
          21
          value
          15
        8. group Id
          BG007
          lower Limit
          1
          upper Limit
          21
          value
          15
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          155
        4. group Id
          BG003
          value
          288
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          81
        7. group Id
          BG006
          value
          77
        8. group Id
          BG007
          value
          815
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          227
        4. group Id
          BG003
          value
          283
        5. group Id
          BG004
          value
          26
        6. group Id
          BG005
          value
          72
        7. group Id
          BG006
          value
          76
        8. group Id
          BG007
          value
          919
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          74
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          22
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          259
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          293
        3. group Id
          BG002
          value
          306
        4. group Id
          BG003
          value
          487
        5. group Id
          BG004
          value
          34
        6. group Id
          BG005
          value
          127
        7. group Id
          BG006
          value
          134
        8. group Id
          BG007
          value
          1425
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          50
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          50
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          6
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          67
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          194
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          290
        3. group Id
          BG002
          value
          297
        4. group Id
          BG003
          value
          444
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          122
        7. group Id
          BG006
          value
          124
        8. group Id
          BG007
          value
          1348
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          132
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
      title
      New Zealand
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          51
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          175
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          312
        4. group Id
          BG003
          value
          491
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          125
        7. group Id
          BG006
          value
          128
        8. group Id
          BG007
          value
          1469
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          6
      title
      Israel
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          40
      title
      Australia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Switzerland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Kuwait
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      France
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          22
      title
      Netherlands
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          13
      title
      Puerto Rico
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Bermuda
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      French Polynesia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice