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NCT03548285 · FLOW

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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.

groups
  1. description
    Radiation therapy: Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (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
    FG000
    title
    Patients Receiving SBRT Treatment
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Radiation therapy: Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (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
    FG000
    title
    Patients Receiving SBRT Treatment
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice