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NCT02912559 · BASELINE

Baseline characteristics

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair · Source last updated 2026-10-01

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
      355
    2. group Id
      BG001
      value
      357
    3. group Id
      BG002
      value
      712
    units
    Participants
groups
  1. description
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
    id
    BG000
    title
    Arm I (Combination Chemotherapy, Atezolizumab)
  2. description
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
    id
    BG001
    title
    Arm II (Combination Chemotherapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          72
          value
          64
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          72
          value
          63
        3. group Id
          BG002
          lower Limit
          49
          upper Limit
          72
          value
          64
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          206
        3. group Id
          BG002
          value
          392
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          320
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          322
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          642
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          22
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          50
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          302
        2. group Id
          BG001
          value
          305
        3. group Id
          BG002
          value
          607
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          27
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          341
        2. group Id
          BG001
          value
          343
        3. group Id
          BG002
          value
          684
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          28
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          463
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          238
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        2
    description
    0 Fully active, able to carry on all pre-disease performance without restriction\> 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\> 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours\> 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours\> 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair\> 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      355
    2. group Id
      BG001
      value
      357
    3. group Id
      BG002
      value
      712
    units
    Participants
groups
  1. description
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
    id
    BG000
    title
    Arm I (Combination Chemotherapy, Atezolizumab)
  2. description
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
    id
    BG001
    title
    Arm II (Combination Chemotherapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          72
          value
          64
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          72
          value
          63
        3. group Id
          BG002
          lower Limit
          49
          upper Limit
          72
          value
          64
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          206
        3. group Id
          BG002
          value
          392
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          320
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          322
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          642
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          22
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          50
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          302
        2. group Id
          BG001
          value
          305
        3. group Id
          BG002
          value
          607
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          27
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          341
        2. group Id
          BG001
          value
          343
        3. group Id
          BG002
          value
          684
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          28
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          463
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          238
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        2
    description
    0 Fully active, able to carry on all pre-disease performance without restriction\> 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\> 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours\> 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours\> 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair\> 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice