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NCT00720083 · FLOW

Participant flow

Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer · Source last updated 2015-11-17

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

groups
  1. description
    Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    RT + Cisplatin
  2. description
    Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    RT + Cisplatin + Vandetanib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. comment
        Subjects with data for the primary analysis are considered to have completed the study.
        group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        13
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
34 subjects were registered, after which 2 did not continue to randomization due to physician preference.
Complete source fields
groups
  1. description
    Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    RT + Cisplatin
  2. description
    Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    RT + Cisplatin + Vandetanib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. comment
        Subjects with data for the primary analysis are considered to have completed the study.
        group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        13
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
34 subjects were registered, after which 2 did not continue to randomization due to physician preference.

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Preserved source evidence · Not medical advice