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NCT00084838 · BASELINE

Baseline characteristics

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT · Source last updated 2015-12-24

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
      20
    units
    Participants
groups
  1. description
    Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
    id
    BG000
    title
    Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.2
          upper Limit
          19
          value
          2.2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        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
          20
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      M0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      M2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      M3
    description
    Chang staging: M0 is non-metastatic disease. M1 is CSF +ve disease which means that the tumor cells are found floating in the spinal fluid, M2 is localized metastatic disease and M3 is disseminated bulk disease.
    param Type
    NUMBER
    title
    Chang Stage
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    units
    Participants
groups
  1. description
    Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
    id
    BG000
    title
    Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.2
          upper Limit
          19
          value
          2.2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        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
          20
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      M0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      M2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      M3
    description
    Chang staging: M0 is non-metastatic disease. M1 is CSF +ve disease which means that the tumor cells are found floating in the spinal fluid, M2 is localized metastatic disease and M3 is disseminated bulk disease.
    param Type
    NUMBER
    title
    Chang Stage
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice