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NCT00945724 · BASELINE

Baseline characteristics

Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis · Source last updated 2025-05-30

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
      54
    units
    Participants
groups
  1. description
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15: * 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days * Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle * IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
    id
    BG000
    title
    R-CHOP, Depocyte, Methotrexate
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          27
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          79
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    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
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
      title
      Italy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
      title
      Switzerland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Stage II
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    description
    Ann Arbor staging is the staging system for lymphomas. The stage depends on the place where the malignant tissue is located. * Stage I indicates that the cancer is located in a single region, usually one lymph node and the surrounding area. * Stage II indicates that the cancer is located in two separate regions, an affected lymph node or lymphatic organ and a second affected area, both affected areas are confined to one side of the diaphragm. Stage II indicates a worse outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ann Arbor stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Bilateral testicular location
      2. measurements
        1. group Id
          BG000
          value
          53
        title
        No bilateral testicular location
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bilateral testicular location
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Presence of B symptoms
      2. measurements
        1. group Id
          BG000
          value
          52
        title
        No Presence of B symptoms
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    description
    B symptoms include fever, night sweats and weight loss of ≥10% of body weight over 6 months. Presence of B symptoms indicates a worse outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    B symptoms
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        > normal upper value
      2. measurements
        1. group Id
          BG000
          value
          47
        title
        </= normal upper value
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum lactate dehydrogenase (LDH)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        > normal upper value
      2. measurements
        1. group Id
          BG000
          value
          40
        title
        </= normal upper value
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        Not recorded
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Beta2-microglobulin
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      54
    units
    Participants
groups
  1. description
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15: * 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days * Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle * IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
    id
    BG000
    title
    R-CHOP, Depocyte, Methotrexate
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          27
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          79
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    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
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
      title
      Italy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
      title
      Switzerland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Stage II
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    description
    Ann Arbor staging is the staging system for lymphomas. The stage depends on the place where the malignant tissue is located. * Stage I indicates that the cancer is located in a single region, usually one lymph node and the surrounding area. * Stage II indicates that the cancer is located in two separate regions, an affected lymph node or lymphatic organ and a second affected area, both affected areas are confined to one side of the diaphragm. Stage II indicates a worse outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ann Arbor stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Bilateral testicular location
      2. measurements
        1. group Id
          BG000
          value
          53
        title
        No bilateral testicular location
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bilateral testicular location
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Presence of B symptoms
      2. measurements
        1. group Id
          BG000
          value
          52
        title
        No Presence of B symptoms
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    description
    B symptoms include fever, night sweats and weight loss of ≥10% of body weight over 6 months. Presence of B symptoms indicates a worse outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    B symptoms
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        > normal upper value
      2. measurements
        1. group Id
          BG000
          value
          47
        title
        </= normal upper value
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum lactate dehydrogenase (LDH)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        > normal upper value
      2. measurements
        1. group Id
          BG000
          value
          40
        title
        </= normal upper value
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        Not recorded
      denoms
      1. counts
        1. group Id
          BG000
          value
          54
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Beta2-microglobulin
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice