Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01898494 · FLOW

Participant flow

Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer · Source last updated 2026-04-01

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

groups
  1. description
    Patients receive observation after transoral surgery.
    id
    FG000
    title
    Arm S (Transoral Surgery) Then Arm A (Observation)
  2. description
    Patients under go transoral surgery and then receive low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.
    id
    FG001
    title
    Arm S (Transoral Surgery) Then Arm B (Radiotherapy IMRT 50 Gy)
  3. description
    Patients undergo transoral surgery and then receive standard-dose (60Gy) IMRT QD over 30 fractions.
    id
    FG002
    title
    Arm S (Transoral Surgery) Then Arm C (Radiotherapy IMRT 60 Gy)
  4. description
    Patients undergo transoral surgery and then receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes or carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
    id
    FG003
    title
    Arm S (Transoral Surgery) Then Arm D (Chemo + IMRT 66 Gy)
  5. description
    Patients either did not receive transoral surgery at Step 1 or were not assigned to Step 2 treatment arms.
    id
    FG004
    title
    Not Being Assigned to Step 2 Adjuvant Treatment Arms
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        7
      type
      Patient ineligible
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Alternative therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Surgery planned but not performed
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        132
      4. group Id
        FG003
        num Subjects
        138
      5. group Id
        FG004
        num Subjects
        74
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        132
      4. group Id
        FG003
        num Subjects
        138
      5. group Id
        FG004
        num Subjects
        50
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Step 1 (Arm S - Transoral Surgery)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Never started treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        132
      4. group Id
        FG003
        num Subjects
        138
      5. comment
        This group of patients did not proceed to adjuvant treatment on this study. They either received surgery but did not proceed to adjuvant treatment or did not receive surgery in Step 1.
        group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        127
      4. group Id
        FG003
        num Subjects
        134
      5. group Id
        FG004
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        100
      3. group Id
        FG002
        num Subjects
        108
      4. group Id
        FG003
        num Subjects
        113
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        99
      4. group Id
        FG003
        num Subjects
        102
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated Patients With Baseline MDADI Assessed
    5. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        88
      4. group Id
        FG003
        num Subjects
        94
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated Patients With Post-surgery MDADI Assessed
    6. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        75
      3. group Id
        FG002
        num Subjects
        80
      4. group Id
        FG003
        num Subjects
        77
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated Patients With FACT-H&N Assessed at 6 Months
    7. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        118
      4. group Id
        FG003
        num Subjects
        127
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2 (Adjuvant Treatment)
recruitment Details
The study was activated on July 9, 2013, accrued its first patient on January 22, 2014, and closed to accrual on July 7, 2017 for a total of 519 patients.
Complete source fields
groups
  1. description
    Patients receive observation after transoral surgery.
    id
    FG000
    title
    Arm S (Transoral Surgery) Then Arm A (Observation)
  2. description
    Patients under go transoral surgery and then receive low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions.
    id
    FG001
    title
    Arm S (Transoral Surgery) Then Arm B (Radiotherapy IMRT 50 Gy)
  3. description
    Patients undergo transoral surgery and then receive standard-dose (60Gy) IMRT QD over 30 fractions.
    id
    FG002
    title
    Arm S (Transoral Surgery) Then Arm C (Radiotherapy IMRT 60 Gy)
  4. description
    Patients undergo transoral surgery and then receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes or carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
    id
    FG003
    title
    Arm S (Transoral Surgery) Then Arm D (Chemo + IMRT 66 Gy)
  5. description
    Patients either did not receive transoral surgery at Step 1 or were not assigned to Step 2 treatment arms.
    id
    FG004
    title
    Not Being Assigned to Step 2 Adjuvant Treatment Arms
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        7
      type
      Patient ineligible
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Alternative therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Surgery planned but not performed
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        132
      4. group Id
        FG003
        num Subjects
        138
      5. group Id
        FG004
        num Subjects
        74
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        132
      4. group Id
        FG003
        num Subjects
        138
      5. group Id
        FG004
        num Subjects
        50
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Step 1 (Arm S - Transoral Surgery)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Never started treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        132
      4. group Id
        FG003
        num Subjects
        138
      5. comment
        This group of patients did not proceed to adjuvant treatment on this study. They either received surgery but did not proceed to adjuvant treatment or did not receive surgery in Step 1.
        group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        127
      4. group Id
        FG003
        num Subjects
        134
      5. group Id
        FG004
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        100
      3. group Id
        FG002
        num Subjects
        108
      4. group Id
        FG003
        num Subjects
        113
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        91
      3. group Id
        FG002
        num Subjects
        99
      4. group Id
        FG003
        num Subjects
        102
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated Patients With Baseline MDADI Assessed
    5. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        83
      3. group Id
        FG002
        num Subjects
        88
      4. group Id
        FG003
        num Subjects
        94
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated Patients With Post-surgery MDADI Assessed
    6. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        75
      3. group Id
        FG002
        num Subjects
        80
      4. group Id
        FG003
        num Subjects
        77
      5. group Id
        FG004
        num Subjects
        0
      type
      Eligible and Treated Patients With FACT-H&N Assessed at 6 Months
    7. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        118
      4. group Id
        FG003
        num Subjects
        127
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2 (Adjuvant Treatment)
recruitment Details
The study was activated on July 9, 2013, accrued its first patient on January 22, 2014, and closed to accrual on July 7, 2017 for a total of 519 patients.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice