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NCT03258554 · OUTCOME

Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) Physical Functioning Score at One Year

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.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline and one year after end of radiation therapy (approximately 7 weeks)

What was measured

The EORTC QLQ C30 Physical Functioning score measures patient reported limitations in physical activities. Possible scores for each score range from 0 to 100, with higher scores indicating better physical functioning. Change is defined as the time point score minus the baseline score, where positive values indicate improvement for and negative values indicate.

Analysis population: Randomized participants with baseline and one-year data.

Groups in this outcome

RT+ Cetuximab

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.

RT + Durvalumab

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.

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

Analysis denominator · Participants

GroupSource count
RT+ Cetuximab28
RT + Durvalumab58

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT+ Cetuximab-1.90Not reported-12.248.43Not reported
RT + Durvalumab-1.49Not reported-6.233.24Not 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
    SUPERIORITY
    p Value
    0.9416
    p Value Comment
    Two-sided significance level = 0.05
    statistical Comment
    Welch t-test (unequal variances)
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.9416
    p Value Comment
    Two-sided significance level = 0.05
    statistical Comment
    Welch t-test (unequal variances)
    statistical Method
    t-test, 2 sided
anticipated Posting Date
2026-06
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.24
        upper Limit
        8.43
        value
        -1.90
      2. group Id
        OG001
        lower Limit
        -6.23
        upper Limit
        3.24
        value
        -1.49
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      58
    units
    Participants
description
The EORTC QLQ C30 Physical Functioning score measures patient reported limitations in physical activities. Possible scores for each score range from 0 to 100, with higher scores indicating better physical functioning. Change is defined as the time point score minus the baseline score, where positive values indicate improvement for and negative values indicate.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    RT+ Cetuximab
  2. 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
    OG001
    title
    RT + Durvalumab
param Type
MEAN
population Description
Randomized participants with baseline and one-year data.
reporting Status
POSTED
time Frame
Baseline and one year after end of radiation therapy (approximately 7 weeks)
title
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) Physical Functioning Score at One Year
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice