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NCT03552965 · OUTCOME

Grade of Xerostomia

Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC · Source last updated 2025-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline

What was measured

Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

Analysis population: There were missing data.

Groups in this outcome

Margin-Based Radiotherapy Planning

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area. Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area

Robust Radiotherapy Planning

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue. Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Margin-Based Radiotherapy Planning7
Robust Radiotherapy Planning12

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Margin-Based Radiotherapy Planning1.140.378Not reportedNot reportedNot reported
Robust Radiotherapy Planning1.170.577Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    other Analysis Description
    Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time. Margin-based: Mean=1.14, SD=0.378, Range=1, 25th percentile=1, Median=1, 75th percentile=1, n=7 Robust: Mean=1.17, SD=0.577, Range=2, 25th percentile=1, Median=1, 75th percentile=1, n=12
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    other Analysis Description
    Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time. Margin-based: Mean=1.14, SD=0.378, Range=1, 25th percentile=1, Median=1, 75th percentile=1, n=7 Robust: Mean=1.17, SD=0.577, Range=2, 25th percentile=1, Median=1, 75th percentile=1, n=12
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.378
        value
        1.14
      2. group Id
        OG001
        spread
        0.577
        value
        1.17
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.
dispersion Type
Standard Deviation
groups
  1. description
    This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area. Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
    id
    OG000
    title
    Margin-Based Radiotherapy Planning
  2. description
    This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue. Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
    id
    OG001
    title
    Robust Radiotherapy Planning
param Type
MEAN
population Description
There were missing data.
reporting Status
POSTED
time Frame
Baseline
title
Grade of Xerostomia
type
PRIMARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice