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NCT03548285 · BASELINE

Baseline characteristics

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer · Source last updated 2025-05-22

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
      25
    units
    Participants
groups
  1. description
    All patients on the clinical trial are receiving SBRT. Early-stage larynx cancer patients; all patients received SBRT (study treatment) at one of two different dose levels based on cohort (determined by whether the patient was low or moderate risk). The treatment fields are identical in both cohorts, and are expected to have the same patterns-of-failure. The dosing of these patients is not experimental and therefore was not a factor in analysis: all patients were analyzed together, as all received the same experimental treatment (SBRT). The biologically effective dose of this regimen is identical according to EQD2 (equivalent dose in 2 Gray fractions) analysis; in 5 fractions, the dose was equivalent to 65.52 Gy, and in 16 fractions, the dose was equivalent to 65.28 Gy. Therefore the biological impact of both regimens was the same, and this equivalence is why we analyzed the AE's together. The only potential difference between these dosing regimens is in late effects (1 year and after), but we saw no grade 2 or higher adverse events in either cohort, eliminating the need to report out late adverse events separately.
    id
    BG000
    title
    Patients Receiving SBRT
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          65
          upper Limit
          81
          value
          72
      title
      Age of patients
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        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
          8
      title
      None
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Previous
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Active
    param Type
    NUMBER
    title
    Smoking
    unit Of Measure
    participants
population Description
Early stage larynx cancer patients receiving SBRT; additional details in participant flow
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      25
    units
    Participants
groups
  1. description
    All patients on the clinical trial are receiving SBRT. Early-stage larynx cancer patients; all patients received SBRT (study treatment) at one of two different dose levels based on cohort (determined by whether the patient was low or moderate risk). The treatment fields are identical in both cohorts, and are expected to have the same patterns-of-failure. The dosing of these patients is not experimental and therefore was not a factor in analysis: all patients were analyzed together, as all received the same experimental treatment (SBRT). The biologically effective dose of this regimen is identical according to EQD2 (equivalent dose in 2 Gray fractions) analysis; in 5 fractions, the dose was equivalent to 65.52 Gy, and in 16 fractions, the dose was equivalent to 65.28 Gy. Therefore the biological impact of both regimens was the same, and this equivalence is why we analyzed the AE's together. The only potential difference between these dosing regimens is in late effects (1 year and after), but we saw no grade 2 or higher adverse events in either cohort, eliminating the need to report out late adverse events separately.
    id
    BG000
    title
    Patients Receiving SBRT
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          65
          upper Limit
          81
          value
          72
      title
      Age of patients
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        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
          8
      title
      None
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Previous
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Active
    param Type
    NUMBER
    title
    Smoking
    unit Of Measure
    participants
population Description
Early stage larynx cancer patients receiving SBRT; additional details in participant flow

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Preserved source evidence · Not medical advice