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NCT00956007 · OUTCOME

Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer · Source last updated 2026-01-06

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From start of radiation therapy to 90 days

What was measured

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.

Analysis population: Randomized eligible participants who started protocol treatment

Groups in this outcome

IMRT

Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).

IMRT Plus Cetuximab

Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.

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

Analysis denominator · Participants

GroupSource count
IMRT282
IMRT Plus Cetuximab276

Reported measurements

Dysphagia
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT13.1Not reported9.717.6Not reported
IMRT Plus Cetuximab21.7Not reported17.327.0Not reported
Dry mouth (xerostomia)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT3.5Not reported1.96.4Not reported
IMRT Plus Cetuximab1.8Not reported0.84.2Not reported
Dermatitis radiation
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT6.4Not reported4.19.9Not reported
IMRT Plus Cetuximab17.0Not reported13.121.9Not reported
Rash acneiform
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT0.0Not reported0.01.3Not reported
IMRT Plus Cetuximab13.4Not reported9.917.9Not reported

Source statistical analyses

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

  1. group Description
    Dysphagia
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0075
    statistical Method
    Fisher Exact
  2. group Description
    Dry mouth
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2955
    statistical Method
    Fisher Exact
  3. group Description
    Dermatitis radiation
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    statistical Method
    Fisher Exact
  4. group Description
    Rach acneiform
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Dysphagia
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0075
    statistical Method
    Fisher Exact
  2. group Description
    Dry mouth
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2955
    statistical Method
    Fisher Exact
  3. group Description
    Dermatitis radiation
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    statistical Method
    Fisher Exact
  4. group Description
    Rach acneiform
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.7
        upper Limit
        17.6
        value
        13.1
      2. group Id
        OG001
        lower Limit
        17.3
        upper Limit
        27.0
        value
        21.7
    title
    Dysphagia
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        6.4
        value
        3.5
      2. group Id
        OG001
        lower Limit
        0.8
        upper Limit
        4.2
        value
        1.8
    title
    Dry mouth (xerostomia)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        9.9
        value
        6.4
      2. group Id
        OG001
        lower Limit
        13.1
        upper Limit
        21.9
        value
        17.0
    title
    Dermatitis radiation
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        1.3
        value
        0.0
      2. group Id
        OG001
        lower Limit
        9.9
        upper Limit
        17.9
        value
        13.4
    title
    Rash acneiform
denoms
  1. counts
    1. group Id
      OG000
      value
      282
    2. group Id
      OG001
      value
      276
    units
    Participants
description
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
    id
    OG000
    title
    IMRT
  2. description
    Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
    id
    OG001
    title
    IMRT Plus Cetuximab
param Type
NUMBER
population Description
Randomized eligible participants who started protocol treatment
reporting Status
POSTED
time Frame
From start of radiation therapy to 90 days
title
Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice