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NCT01013649 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      163
    2. group Id
      BG001
      value
      159
    3. group Id
      BG002
      value
      174
    4. group Id
      BG003
      value
      180
    5. group Id
      BG004
      value
      676
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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 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
    BG003
    title
    Arm IV (Chemotherapy, Chemoradiotherapy)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG004
          value
          35
        title
        ≤ 49
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          37
        3. group Id
          BG004
          value
          79
        title
        50 - 59
      3. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          59
        3. group Id
          BG004
          value
          116
        title
        60 - 69
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          41
        3. group Id
          BG004
          value
          76
        title
        70 - 79
      5. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG004
          value
          16
        title
        ≥ 80
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II Analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          17
        2. group Id
          BG003
          value
          16
        3. group Id
          BG004
          value
          33
        title
        ≤ 49
      2. measurements
        1. group Id
          BG002
          value
          44
        2. group Id
          BG003
          value
          44
        3. group Id
          BG004
          value
          88
        title
        50 - 59
      3. measurements
        1. group Id
          BG002
          value
          63
        2. group Id
          BG003
          value
          72
        3. group Id
          BG004
          value
          135
        title
        60 - 69
      4. measurements
        1. group Id
          BG002
          value
          43
        2. group Id
          BG003
          value
          40
        3. group Id
          BG004
          value
          83
        title
        70 - 79
      5. measurements
        1. group Id
          BG002
          value
          7
        2. group Id
          BG003
          value
          8
        3. group Id
          BG004
          value
          15
        title
        ≥ 80
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          63
        3. group Id
          BG004
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          96
        3. group Id
          BG004
          value
          184
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          74
        2. group Id
          BG003
          value
          85
        3. group Id
          BG004
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG002
          value
          100
        2. group Id
          BG003
          value
          95
        3. group Id
          BG004
          value
          195
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG004
          value
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          143
        3. group Id
          BG004
          value
          286
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG004
          value
          18
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          10
        2. group Id
          BG003
          value
          14
        3. group Id
          BG004
          value
          24
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG002
          value
          158
        2. group Id
          BG003
          value
          162
        3. group Id
          BG004
          value
          320
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG002
          value
          6
        2. group Id
          BG003
          value
          4
        3. group Id
          BG004
          value
          10
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG004
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          22
        3. group Id
          BG004
          value
          32
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          144
        2. group Id
          BG001
          value
          129
        3. group Id
          BG004
          value
          273
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG004
          value
          7
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          1
        2. group Id
          BG003
          value
          1
        3. group Id
          BG004
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG002
          value
          4
        2. group Id
          BG003
          value
          8
        3. group Id
          BG004
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG003
          value
          2
        3. group Id
          BG004
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG002
          value
          19
        2. group Id
          BG003
          value
          27
        3. group Id
          BG004
          value
          46
        title
        Black or African American
      5. measurements
        1. group Id
          BG002
          value
          147
        2. group Id
          BG003
          value
          139
        3. group Id
          BG004
          value
          286
        title
        White
      6. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG002
          value
          3
        2. group Id
          BG003
          value
          3
        3. group Id
          BG004
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.0
          upper Limit
          7.5
          value
          3.0
        2. group Id
          BG001
          lower Limit
          1.0
          upper Limit
          7.6
          value
          3.0
        3. group Id
          BG004
          lower Limit
          1.0
          upper Limit
          7.6
          value
          3.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          lower Limit
          0.9
          upper Limit
          7.9
          value
          3.0
        2. group Id
          BG003
          lower Limit
          1.0
          upper Limit
          6.5
          value
          3.0
        3. group Id
          BG004
          lower Limit
          0.9
          upper Limit
          7.9
          value
          3.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    From pathologic specimen.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Tumor size largest dimension
    unit Of Measure
    centimeters
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          78
        3. group Id
          BG004
          value
          143
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          81
        3. group Id
          BG004
          value
          179
        title
        1
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          72
        2. group Id
          BG003
          value
          83
        3. group Id
          BG004
          value
          155
        title
        0
      2. measurements
        1. group Id
          BG002
          value
          102
        2. group Id
          BG003
          value
          97
        3. group Id
          BG004
          value
          199
        title
        1
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \<50% in bed during the day; 3 = Symptomatic, \>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Zubrod Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          153
        3. group Id
          BG004
          value
          307
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG004
          value
          15
        title
        Intraductal papillary mucinous neoplasm with invasive adenocarcinoma
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          166
        2. group Id
          BG003
          value
          172
        3. group Id
          BG004
          value
          338
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG002
          value
          8
        2. group Id
          BG003
          value
          8
        3. group Id
          BG004
          value
          16
        title
        Intraductal papillary mucinous neoplasm with invasive adenocarcinoma
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    A description of a tumor based on how the cancer cells and tissue look under a microscope.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Histologic Type
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG004
          value
          15
        title
        T1
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          25
        3. group Id
          BG004
          value
          55
        title
        T2
      3. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          126
        3. group Id
          BG004
          value
          252
        title
        T3
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          2
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          14
        title
        T1
      2. measurements
        1. group Id
          BG002
          value
          27
        2. group Id
          BG003
          value
          25
        3. group Id
          BG004
          value
          52
        title
        T2
      3. measurements
        1. group Id
          BG002
          value
          145
        2. group Id
          BG003
          value
          143
        3. group Id
          BG004
          value
          288
        title
        T3
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Pathologic T-Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          40
        3. group Id
          BG004
          value
          85
        title
        N0
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          119
        3. group Id
          BG004
          value
          237
        title
        N1
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          42
        2. group Id
          BG003
          value
          49
        3. group Id
          BG004
          value
          91
        title
        N0
      2. measurements
        1. group Id
          BG002
          value
          132
        2. group Id
          BG003
          value
          131
        3. group Id
          BG004
          value
          263
        title
        N1
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 6th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. N0 means lymph nodes aren't involved. A higher number means the cancer is in more lymph nodes, farther away from the original tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Pathologic N-Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          40
        3. group Id
          BG004
          value
          85
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          78
        3. group Id
          BG004
          value
          154
        title
        1-3
      3. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          41
        3. group Id
          BG004
          value
          83
        title
        >3
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          42
        2. group Id
          BG003
          value
          49
        3. group Id
          BG004
          value
          91
        title
        0
      2. measurements
        1. group Id
          BG002
          value
          95
        2. group Id
          BG003
          value
          79
        3. group Id
          BG004
          value
          174
        title
        1-3
      3. measurements
        1. group Id
          BG002
          value
          37
        2. group Id
          BG003
          value
          52
        3. group Id
          BG004
          value
          89
        title
        >3
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II analysis and phase III analysis.
    title
    Number of Positive Lymph Nodes
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          148
        3. group Id
          BG004
          value
          300
        title
        ≤ 90
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG004
          value
          22
        title
        >90-180
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          163
        2. group Id
          BG003
          value
          177
        3. group Id
          BG004
          value
          340
        title
        ≤ 90
      2. measurements
        1. group Id
          BG002
          value
          11
        2. group Id
          BG003
          value
          3
        3. group Id
          BG004
          value
          14
        title
        >90-180
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    CA 19-9 is a protein found on the surface of some cancer cells, and is also known as sialyl-Lewis A. It is a tumor marker that is commonly used to help diagnose, manage, and predict pancreatic ductal adenocarcinoma (PDAC). CA 19-9 levels are determined by a blood test and are often elevated in patients with advanced pancreatic cancer.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Carbohydrate antigen 19-9 (CA19-9) Level
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG004
          value
          53
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          133
        3. group Id
          BG004
          value
          269
        title
        Negative
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          30
        2. group Id
          BG003
          value
          29
        3. group Id
          BG004
          value
          59
        title
        Positive
      2. measurements
        1. group Id
          BG002
          value
          144
        2. group Id
          BG003
          value
          151
        3. group Id
          BG004
          value
          295
        title
        Negative
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Surgical margins
    unit Of Measure
    Participants
population Description
Arm 1 and Arm 2: Phase II analysis population = eligible randomized Step 1 participants. Arm 3 and Arm 4: Phase III analysis population = randomized Step 2 participants. Phase II and phase III components are reported separately for clarity and so that totals can be seen for each component. Note that 354 participants were in both components.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      163
    2. group Id
      BG001
      value
      159
    3. group Id
      BG002
      value
      174
    4. group Id
      BG003
      value
      180
    5. group Id
      BG004
      value
      676
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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 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
    BG003
    title
    Arm IV (Chemotherapy, Chemoradiotherapy)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG004
          value
          35
        title
        ≤ 49
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          37
        3. group Id
          BG004
          value
          79
        title
        50 - 59
      3. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          59
        3. group Id
          BG004
          value
          116
        title
        60 - 69
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          41
        3. group Id
          BG004
          value
          76
        title
        70 - 79
      5. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG004
          value
          16
        title
        ≥ 80
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II Analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          17
        2. group Id
          BG003
          value
          16
        3. group Id
          BG004
          value
          33
        title
        ≤ 49
      2. measurements
        1. group Id
          BG002
          value
          44
        2. group Id
          BG003
          value
          44
        3. group Id
          BG004
          value
          88
        title
        50 - 59
      3. measurements
        1. group Id
          BG002
          value
          63
        2. group Id
          BG003
          value
          72
        3. group Id
          BG004
          value
          135
        title
        60 - 69
      4. measurements
        1. group Id
          BG002
          value
          43
        2. group Id
          BG003
          value
          40
        3. group Id
          BG004
          value
          83
        title
        70 - 79
      5. measurements
        1. group Id
          BG002
          value
          7
        2. group Id
          BG003
          value
          8
        3. group Id
          BG004
          value
          15
        title
        ≥ 80
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          63
        3. group Id
          BG004
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          96
        3. group Id
          BG004
          value
          184
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          74
        2. group Id
          BG003
          value
          85
        3. group Id
          BG004
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG002
          value
          100
        2. group Id
          BG003
          value
          95
        3. group Id
          BG004
          value
          195
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG004
          value
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          143
        3. group Id
          BG004
          value
          286
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG004
          value
          18
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          10
        2. group Id
          BG003
          value
          14
        3. group Id
          BG004
          value
          24
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG002
          value
          158
        2. group Id
          BG003
          value
          162
        3. group Id
          BG004
          value
          320
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG002
          value
          6
        2. group Id
          BG003
          value
          4
        3. group Id
          BG004
          value
          10
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG004
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          22
        3. group Id
          BG004
          value
          32
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          144
        2. group Id
          BG001
          value
          129
        3. group Id
          BG004
          value
          273
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG004
          value
          7
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          1
        2. group Id
          BG003
          value
          1
        3. group Id
          BG004
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG002
          value
          4
        2. group Id
          BG003
          value
          8
        3. group Id
          BG004
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG003
          value
          2
        3. group Id
          BG004
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG002
          value
          19
        2. group Id
          BG003
          value
          27
        3. group Id
          BG004
          value
          46
        title
        Black or African American
      5. measurements
        1. group Id
          BG002
          value
          147
        2. group Id
          BG003
          value
          139
        3. group Id
          BG004
          value
          286
        title
        White
      6. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG002
          value
          3
        2. group Id
          BG003
          value
          3
        3. group Id
          BG004
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.0
          upper Limit
          7.5
          value
          3.0
        2. group Id
          BG001
          lower Limit
          1.0
          upper Limit
          7.6
          value
          3.0
        3. group Id
          BG004
          lower Limit
          1.0
          upper Limit
          7.6
          value
          3.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          lower Limit
          0.9
          upper Limit
          7.9
          value
          3.0
        2. group Id
          BG003
          lower Limit
          1.0
          upper Limit
          6.5
          value
          3.0
        3. group Id
          BG004
          lower Limit
          0.9
          upper Limit
          7.9
          value
          3.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    From pathologic specimen.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Tumor size largest dimension
    unit Of Measure
    centimeters
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          78
        3. group Id
          BG004
          value
          143
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          81
        3. group Id
          BG004
          value
          179
        title
        1
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          72
        2. group Id
          BG003
          value
          83
        3. group Id
          BG004
          value
          155
        title
        0
      2. measurements
        1. group Id
          BG002
          value
          102
        2. group Id
          BG003
          value
          97
        3. group Id
          BG004
          value
          199
        title
        1
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \<50% in bed during the day; 3 = Symptomatic, \>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Zubrod Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          153
        3. group Id
          BG004
          value
          307
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG004
          value
          15
        title
        Intraductal papillary mucinous neoplasm with invasive adenocarcinoma
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          166
        2. group Id
          BG003
          value
          172
        3. group Id
          BG004
          value
          338
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG002
          value
          8
        2. group Id
          BG003
          value
          8
        3. group Id
          BG004
          value
          16
        title
        Intraductal papillary mucinous neoplasm with invasive adenocarcinoma
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    A description of a tumor based on how the cancer cells and tissue look under a microscope.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Histologic Type
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG004
          value
          15
        title
        T1
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          25
        3. group Id
          BG004
          value
          55
        title
        T2
      3. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          126
        3. group Id
          BG004
          value
          252
        title
        T3
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          2
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          14
        title
        T1
      2. measurements
        1. group Id
          BG002
          value
          27
        2. group Id
          BG003
          value
          25
        3. group Id
          BG004
          value
          52
        title
        T2
      3. measurements
        1. group Id
          BG002
          value
          145
        2. group Id
          BG003
          value
          143
        3. group Id
          BG004
          value
          288
        title
        T3
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Pathologic T-Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          40
        3. group Id
          BG004
          value
          85
        title
        N0
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          119
        3. group Id
          BG004
          value
          237
        title
        N1
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          42
        2. group Id
          BG003
          value
          49
        3. group Id
          BG004
          value
          91
        title
        N0
      2. measurements
        1. group Id
          BG002
          value
          132
        2. group Id
          BG003
          value
          131
        3. group Id
          BG004
          value
          263
        title
        N1
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 6th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. N0 means lymph nodes aren't involved. A higher number means the cancer is in more lymph nodes, farther away from the original tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Pathologic N-Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          40
        3. group Id
          BG004
          value
          85
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          78
        3. group Id
          BG004
          value
          154
        title
        1-3
      3. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          41
        3. group Id
          BG004
          value
          83
        title
        >3
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          42
        2. group Id
          BG003
          value
          49
        3. group Id
          BG004
          value
          91
        title
        0
      2. measurements
        1. group Id
          BG002
          value
          95
        2. group Id
          BG003
          value
          79
        3. group Id
          BG004
          value
          174
        title
        1-3
      3. measurements
        1. group Id
          BG002
          value
          37
        2. group Id
          BG003
          value
          52
        3. group Id
          BG004
          value
          89
        title
        >3
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II analysis and phase III analysis.
    title
    Number of Positive Lymph Nodes
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          148
        3. group Id
          BG004
          value
          300
        title
        ≤ 90
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG004
          value
          22
        title
        >90-180
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          163
        2. group Id
          BG003
          value
          177
        3. group Id
          BG004
          value
          340
        title
        ≤ 90
      2. measurements
        1. group Id
          BG002
          value
          11
        2. group Id
          BG003
          value
          3
        3. group Id
          BG004
          value
          14
        title
        >90-180
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    description
    CA 19-9 is a protein found on the surface of some cancer cells, and is also known as sialyl-Lewis A. It is a tumor marker that is commonly used to help diagnose, manage, and predict pancreatic ductal adenocarcinoma (PDAC). CA 19-9 levels are determined by a blood test and are often elevated in patients with advanced pancreatic cancer.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Carbohydrate antigen 19-9 (CA19-9) Level
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG004
          value
          53
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          133
        3. group Id
          BG004
          value
          269
        title
        Negative
      denoms
      1. counts
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          322
        units
        Participants
      title
      Phase II analysis
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          30
        2. group Id
          BG003
          value
          29
        3. group Id
          BG004
          value
          59
        title
        Positive
      2. measurements
        1. group Id
          BG002
          value
          144
        2. group Id
          BG003
          value
          151
        3. group Id
          BG004
          value
          295
        title
        Negative
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          180
        5. group Id
          BG004
          value
          354
        units
        Participants
      title
      Phase III analysis
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline characteristics are reported separately for phase II and phase III components.
    title
    Surgical margins
    unit Of Measure
    Participants
population Description
Arm 1 and Arm 2: Phase II analysis population = eligible randomized Step 1 participants. Arm 3 and Arm 4: Phase III analysis population = randomized Step 2 participants. Phase II and phase III components are reported separately for clarity and so that totals can be seen for each component. Note that 354 participants were in both components.

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