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NCT00588770 · FLOW

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Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma · Source last updated 2026-08-28

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

groups
  1. description
    ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Chemotherapy Arm (Arm A)
  2. description
    ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
    id
    FG001
    title
    Chemotherapy+Bevacizumab (Arm B)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        68
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        58
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        22
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        25
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      Not start protocol therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        10
      type
      Lack of Efficacy
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician discretion
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Patient non-compliance
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        200
      2. group Id
        FG001
        num Subjects
        203
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        188
      2. group Id
        FG001
        num Subjects
        183
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        200
      2. group Id
        FG001
        num Subjects
        194
      type
      Start Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        200
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
E1305 was activated on August 8, 2008 and closed on February 11,2015, with final accrual of 403 patients.
Complete source fields
groups
  1. description
    ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Chemotherapy Arm (Arm A)
  2. description
    ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
    id
    FG001
    title
    Chemotherapy+Bevacizumab (Arm B)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        68
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        58
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        22
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        25
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      Not start protocol therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        10
      type
      Lack of Efficacy
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician discretion
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Patient non-compliance
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        200
      2. group Id
        FG001
        num Subjects
        203
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        188
      2. group Id
        FG001
        num Subjects
        183
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        200
      2. group Id
        FG001
        num Subjects
        194
      type
      Start Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        200
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
E1305 was activated on August 8, 2008 and closed on February 11,2015, with final accrual of 403 patients.

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Preserved source evidence · Not medical advice