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NCT01013649 · FLOW

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Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery · Source last updated 2026-02-23

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

groups
  1. description
    Patients receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG000
    title
    Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
  2. description
    \[Closed to accrual 2-28-2014.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG001
    title
    Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
  3. description
    Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG002
    title
    Arm III (Chemotherapy)
  4. description
    Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice a day (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG003
    title
    Arm IV (Chemotherapy, Chemoradiotherapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Did not start 5th cycle of first step treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        379
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        169
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Closed 02-28-2014.
      type
      Randomized to Arm I or Arm II
    3. achievements
      1. group Id
        FG000
        num Subjects
        210
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Started 04-02-2014, and as of 06-28-2016, combination chemotherapy was allowed.
      type
      Registered to Arm 1 Only
    4. achievements
      1. group Id
        FG000
        num Subjects
        363
      2. group Id
        FG001
        num Subjects
        159
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Eligible
    5. achievements
      1. group Id
        FG000
        num Subjects
        163
      2. group Id
        FG001
        num Subjects
        159
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Randomized to first step and eligible.
      type
      Phase II Analysis Population
    6. achievements
      1. group Id
        FG000
        num Subjects
        160
      2. group Id
        FG001
        num Subjects
        158
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Randomized to first step, eligible, and started protocol treatment.
      type
      Phase II AE Population
    7. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized to Arm III
    8. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized to Arm IV
    9. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        100
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Participants who continued to second step randomization, which requires starting the 5th cycle of the first step treatment and having no progression detected on the 5th cycle CT/MRI.
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        125
      2. group Id
        FG001
        num Subjects
        67
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    First Step
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      comment
      Randomized to second step (Arm III and Arm IV).
      type
      Phase III Analysis Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      comment
      Randomized to second step, and started protocol treatment.
      type
      Phase III AE Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      comment
      Contributed any data to phase III analysis or adverse event reporting.
      type
      COMPLETED
    5. 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
      type
      NOT COMPLETED
    title
    Second Step
Complete source fields
groups
  1. description
    Patients receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG000
    title
    Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
  2. description
    \[Closed to accrual 2-28-2014.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG001
    title
    Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
  3. description
    Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG002
    title
    Arm III (Chemotherapy)
  4. description
    Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice a day (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    FG003
    title
    Arm IV (Chemotherapy, Chemoradiotherapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Did not start 5th cycle of first step treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        379
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        169
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Closed 02-28-2014.
      type
      Randomized to Arm I or Arm II
    3. achievements
      1. group Id
        FG000
        num Subjects
        210
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Started 04-02-2014, and as of 06-28-2016, combination chemotherapy was allowed.
      type
      Registered to Arm 1 Only
    4. achievements
      1. group Id
        FG000
        num Subjects
        363
      2. group Id
        FG001
        num Subjects
        159
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Eligible
    5. achievements
      1. group Id
        FG000
        num Subjects
        163
      2. group Id
        FG001
        num Subjects
        159
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Randomized to first step and eligible.
      type
      Phase II Analysis Population
    6. achievements
      1. group Id
        FG000
        num Subjects
        160
      2. group Id
        FG001
        num Subjects
        158
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Randomized to first step, eligible, and started protocol treatment.
      type
      Phase II AE Population
    7. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized to Arm III
    8. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized to Arm IV
    9. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        100
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Participants who continued to second step randomization, which requires starting the 5th cycle of the first step treatment and having no progression detected on the 5th cycle CT/MRI.
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        125
      2. group Id
        FG001
        num Subjects
        67
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    First Step
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      comment
      Randomized to second step (Arm III and Arm IV).
      type
      Phase III Analysis Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      comment
      Randomized to second step, and started protocol treatment.
      type
      Phase III AE Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        174
      4. group Id
        FG003
        num Subjects
        180
      comment
      Contributed any data to phase III analysis or adverse event reporting.
      type
      COMPLETED
    5. 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
      type
      NOT COMPLETED
    title
    Second Step

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Preserved source evidence · Not medical advice