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NCT01087970 · FLOW

Participant flow

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2014-05-19

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

groups
  1. description
    Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    id
    FG000
    title
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      Received ≥1 Dose of Any Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      Completed 6 Cycles
    4. achievements
      1. comment
        All treated participants excluding those from a noncompliant study site.
        group Id
        FG000
        num Subjects
        58
      type
      Efficacy Population
    5. achievements
      1. group Id
        FG000
        num Subjects
        63
      type
      Received Carboplatin
    6. achievements
      1. group Id
        FG000
        num Subjects
        67
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    id
    FG000
    title
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      Received ≥1 Dose of Any Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      Completed 6 Cycles
    4. achievements
      1. comment
        All treated participants excluding those from a noncompliant study site.
        group Id
        FG000
        num Subjects
        58
      type
      Efficacy Population
    5. achievements
      1. group Id
        FG000
        num Subjects
        63
      type
      Received Carboplatin
    6. achievements
      1. group Id
        FG000
        num Subjects
        67
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice