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NCT00088881 · FLOW

Participant flow

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma · Source last updated 2017-05-25

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

groups
  1. description
    R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study. Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
    id
    FG000
    title
    Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Patient ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Insurance company refused to cover
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        62
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        53
      type
      Eligible and Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Step 1 - R-CHOP
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Patient ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Other
    milestones
    1. achievements
      1. comment
        This includes all patients who received step 2 treatment regardless of eligibility.
        group Id
        FG000
        num Subjects
        56
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      Eligible and Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Step 2 - Zevalin™ Radioimmunotherapy
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 3 - Radiation Therapy
Complete source fields
groups
  1. description
    R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study. Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
    id
    FG000
    title
    Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Patient ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Insurance company refused to cover
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        62
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        53
      type
      Eligible and Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Step 1 - R-CHOP
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Patient ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Other
    milestones
    1. achievements
      1. comment
        This includes all patients who received step 2 treatment regardless of eligibility.
        group Id
        FG000
        num Subjects
        56
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      Eligible and Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Step 2 - Zevalin™ Radioimmunotherapy
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 3 - Radiation Therapy

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Preserved source evidence · Not medical advice