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NCT01084083 · FLOW

Participant flow

Induction Chemotherapy Followed By Cetuximab and Radiation in HPV-Associated Resectable Stage III/IV Oropharynx Cancer · Source last updated 2023-06-28

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

groups
  1. description
    Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
    id
    FG000
    title
    Overall
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Complicating disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Other
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never started assigned therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        90
      type
      STARTED
    2. achievements
      1. comment
        This is the all treated patients for toxicity analysis
        group Id
        FG000
        num Subjects
        89
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        81
      type
      Eligible
    4. achievements
      1. comment
        This is the eligible and treated patients for secondary efficacy endpoints
        group Id
        FG000
        num Subjects
        80
      type
      Eligible and Treated
    5. achievements
      1. group Id
        FG000
        num Subjects
        56
      type
      CR to Induction Therapy
    6. achievements
      1. comment
        This is the primary study population for the primary endpoint (24-month PFS).
        group Id
        FG000
        num Subjects
        44
      type
      CR and Treated With 5400 cGy IMRT
    7. achievements
      1. group Id
        FG000
        num Subjects
        78
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on March 17, 2010, accrued its first patient on August 11, 2010, and closed to accrual on October 19, 2011, with an accrual of 90 patients from 16 ECOG-affiliated institutions.
Complete source fields
groups
  1. description
    Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
    id
    FG000
    title
    Overall
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Complicating disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Other
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never started assigned therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        90
      type
      STARTED
    2. achievements
      1. comment
        This is the all treated patients for toxicity analysis
        group Id
        FG000
        num Subjects
        89
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        81
      type
      Eligible
    4. achievements
      1. comment
        This is the eligible and treated patients for secondary efficacy endpoints
        group Id
        FG000
        num Subjects
        80
      type
      Eligible and Treated
    5. achievements
      1. group Id
        FG000
        num Subjects
        56
      type
      CR to Induction Therapy
    6. achievements
      1. comment
        This is the primary study population for the primary endpoint (24-month PFS).
        group Id
        FG000
        num Subjects
        44
      type
      CR and Treated With 5400 cGy IMRT
    7. achievements
      1. group Id
        FG000
        num Subjects
        78
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on March 17, 2010, accrued its first patient on August 11, 2010, and closed to accrual on October 19, 2011, with an accrual of 90 patients from 16 ECOG-affiliated institutions.

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Preserved source evidence · Not medical advice