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NCT03258554 · BASELINE

Baseline characteristics

Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin · Source last updated 2026-08-27

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
      10
    2. group Id
      BG001
      value
      63
    3. group Id
      BG002
      value
      123
    4. group Id
      BG003
      value
      196
    units
    Participants
groups
  1. description
    IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    (Lead-in) RT + Durvalumab
  2. description
    IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    RT + Cetuximab
  3. description
    IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    RT + Durvalumab
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
      title
      ≤ 49 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          19
      title
      50 - 59 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          61
      title
      60 - 69 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          88
      title
      70 - 79 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          24
      title
      ≥ 80 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          102
        4. group Id
          BG003
          value
          165
        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
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          173
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          165
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        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
          4
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          80
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          93
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          23
        title
        2
    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
    title
    Zubrod performance status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          71
        title
        0 (no comorbidities)
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          80
        4. group Id
          BG003
          value
          125
        title
        ≥ 1
    description
    An assessment tool used to predict the mortality for a patient who may have a range of concurrent conditions (comorbidities). The score ranges from 0 (no comorbidities) to 35 (highest possible comorbidity load / highest risk of death). For this study, the CCI was modified to exclude the cancer questions: "Has the patient had cancer (other than basal cell skin cancer)?" and "Has the patient had a metastatic solid tumor?".
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Modified Charlson Comorbidity Index (CCI)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          88
        title
        Oropharynx, p16-positive
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Unknown, p16-positive
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          20
        title
        Oropharynx, p16-negative
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown, p16-negative
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        title
        Oral cavity
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          21
        title
        Hypopharynx
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          50
        title
        Larynx
    description
    The biomarker p16 is used as a surrogate marker for human papillomavirus (HPV) infections and is a known prognostic factor in some head and neck cancers.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary tumor site and p16 status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        title
        T0
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          21
        title
        T1
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          56
        title
        T2
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          65
        title
        T3
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          28
        title
        T4
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          17
        title
        T4a
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        T4b
    description
    Tumor stage per the American Joint Committee on Cancer (AJCC) 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. T's may be further divided to provide more detail, such as T3a and T3b. Lead-in component used 7th edition of AJCC; phase II component used 8th edition.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    T stage, clinical (AJCC 8)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          31
        title
        N0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          66
        title
        N1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          29
        title
        N2
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        N2a
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          28
        title
        N2b
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          30
        title
        N2c
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        title
        N3
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        N3a
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        N3b
    description
    Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. The higher the number after the N, the greater the involvement of regional lymph nodes. Lead-in component used 7th edition of AJCC; phase II component used 8th edition.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    N stage, clinical (AJCC 8)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          60
        title
        ≤ 10 pack-years
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          88
        4. group Id
          BG003
          value
          136
        title
        > 10 pack-years
    description
    A way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking history: pack-years
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          162
        title
        Absolute or relative contraindication to cisplatin
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          17
        title
        Age ≥ 70 with moderate to severe comorbidity or vulnerability to cisplatin
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          17
        title
        Age < 70 with severe comorbidity or vulnerability to cisplatin
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Comorbidity group
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          20
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          37
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          50
        title
        5
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          79
        title
        ≥ 6
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of comorbidity conditions
    unit Of Measure
    Participants
population Description
Enrolled participants (i.e. for phase II, randomized)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    2. group Id
      BG001
      value
      63
    3. group Id
      BG002
      value
      123
    4. group Id
      BG003
      value
      196
    units
    Participants
groups
  1. description
    IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    (Lead-in) RT + Durvalumab
  2. description
    IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    RT + Cetuximab
  3. description
    IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    RT + Durvalumab
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
      title
      ≤ 49 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          19
      title
      50 - 59 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          61
      title
      60 - 69 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          88
      title
      70 - 79 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          24
      title
      ≥ 80 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          102
        4. group Id
          BG003
          value
          165
        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
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          173
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          165
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        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
          4
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          80
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          93
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          23
        title
        2
    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
    title
    Zubrod performance status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          71
        title
        0 (no comorbidities)
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          80
        4. group Id
          BG003
          value
          125
        title
        ≥ 1
    description
    An assessment tool used to predict the mortality for a patient who may have a range of concurrent conditions (comorbidities). The score ranges from 0 (no comorbidities) to 35 (highest possible comorbidity load / highest risk of death). For this study, the CCI was modified to exclude the cancer questions: "Has the patient had cancer (other than basal cell skin cancer)?" and "Has the patient had a metastatic solid tumor?".
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Modified Charlson Comorbidity Index (CCI)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          88
        title
        Oropharynx, p16-positive
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Unknown, p16-positive
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          20
        title
        Oropharynx, p16-negative
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown, p16-negative
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        title
        Oral cavity
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          21
        title
        Hypopharynx
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          50
        title
        Larynx
    description
    The biomarker p16 is used as a surrogate marker for human papillomavirus (HPV) infections and is a known prognostic factor in some head and neck cancers.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary tumor site and p16 status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        title
        T0
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          21
        title
        T1
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          56
        title
        T2
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          65
        title
        T3
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          28
        title
        T4
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          17
        title
        T4a
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        T4b
    description
    Tumor stage per the American Joint Committee on Cancer (AJCC) 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. T's may be further divided to provide more detail, such as T3a and T3b. Lead-in component used 7th edition of AJCC; phase II component used 8th edition.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    T stage, clinical (AJCC 8)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          31
        title
        N0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          66
        title
        N1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          29
        title
        N2
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        N2a
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          28
        title
        N2b
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          30
        title
        N2c
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        title
        N3
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        N3a
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        N3b
    description
    Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. The higher the number after the N, the greater the involvement of regional lymph nodes. Lead-in component used 7th edition of AJCC; phase II component used 8th edition.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    N stage, clinical (AJCC 8)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          60
        title
        ≤ 10 pack-years
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          88
        4. group Id
          BG003
          value
          136
        title
        > 10 pack-years
    description
    A way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking history: pack-years
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          162
        title
        Absolute or relative contraindication to cisplatin
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          17
        title
        Age ≥ 70 with moderate to severe comorbidity or vulnerability to cisplatin
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          17
        title
        Age < 70 with severe comorbidity or vulnerability to cisplatin
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Comorbidity group
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          9
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          20
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          37
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          50
        title
        5
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          79
        title
        ≥ 6
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of comorbidity conditions
    unit Of Measure
    Participants
population Description
Enrolled participants (i.e. for phase II, randomized)

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Preserved source evidence · Not medical advice