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NCT00096174 · FLOW

Participant flow

Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-06-29

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

groups
  1. description
    * Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. * Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. * Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
    id
    FG000
    title
    Cisplatin, C225, Radiation
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Not started protocol therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Ineligible
    7. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      other reason
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. comment
        3 patients never started treatment
        group Id
        FG000
        num Subjects
        66
      type
      Began Protocol Therapy
    3. achievements
      1. comment
        6 treated patients were ineligible
        group Id
        FG000
        num Subjects
        60
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        62
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was open to accrual on 12/21/2004, accrued its first patient on April 8, 2005, and was closed on 07/20/2006. The final accrual was 69 patients.
Complete source fields
groups
  1. description
    * Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. * Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. * Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
    id
    FG000
    title
    Cisplatin, C225, Radiation
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Not started protocol therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Ineligible
    7. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      other reason
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. comment
        3 patients never started treatment
        group Id
        FG000
        num Subjects
        66
      type
      Began Protocol Therapy
    3. achievements
      1. comment
        6 treated patients were ineligible
        group Id
        FG000
        num Subjects
        60
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        62
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was open to accrual on 12/21/2004, accrued its first patient on April 8, 2005, and was closed on 07/20/2006. The final accrual was 69 patients.

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Preserved source evidence · Not medical advice