NCT00956007 · OUTCOME

Percentage of Participants With ≥ Grade 3 Late 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 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years.

What was measured

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events 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. Late adverse events are those occurring after days from the start of radiation therapy.

Analysis population: Randomized eligible participants who started protocol treatment and had follow-up data at or after day 91 from start of radiation therapy

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

Group	Source count
IMRT	279
IMRT Plus Cetuximab	268

Reported measurements

Dysphagia

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
IMRT	8.6	Not reported	5.8	12.5	Not reported
IMRT Plus Cetuximab	12.3	Not reported	8.9	16.8	Not reported

Dry mouth (xerostomia)

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
IMRT	3.2	Not reported	1.7	6.0	Not reported
IMRT Plus Cetuximab	1.5	Not reported	0.6	3.8	Not reported

Dermatitis radiation

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
IMRT	1.4	Not reported	0.6	3.6	Not reported
IMRT Plus Cetuximab	2.2	Not reported	1.0	4.8	Not reported

Rash acneiform

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
IMRT	0.0	Not reported	0.0	1.4	Not reported
IMRT Plus Cetuximab	1.5	Not reported	0.6	3.8	Not reported

Source statistical analyses

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

group Description
Dysphagia
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1641
statistical Method
Fisher Exact
group Description
Dry mouth
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2623
statistical Method
Fisher Exact
group Description
Dermatitis radiation
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.5378
statistical Method
Fisher Exact
group Description
Rash acneiform
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0570
statistical Method
Fisher Exact

Complete source fields

analyses

group Description
Dysphagia
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1641
statistical Method
Fisher Exact
group Description
Dry mouth
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2623
statistical Method
Fisher Exact
group Description
Dermatitis radiation
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.5378
statistical Method
Fisher Exact
group Description
Rash acneiform
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0570
statistical Method
Fisher Exact

classes

categories
measurements
group Id
OG000
lower Limit
5.8
upper Limit
12.5
value
8.6
group Id
OG001
lower Limit
8.9
upper Limit
16.8
value
12.3
title
Dysphagia
categories
measurements
group Id
OG000
lower Limit
1.7
upper Limit
6.0
value
3.2
group Id
OG001
lower Limit
0.6
upper Limit
3.8
value
1.5
title
Dry mouth (xerostomia)
categories
measurements
group Id
OG000
lower Limit
0.6
upper Limit
3.6
value
1.4
group Id
OG001
lower Limit
1.0
upper Limit
4.8
value
2.2
title
Dermatitis radiation
categories
measurements
group Id
OG000
lower Limit
0.0
upper Limit
1.4
value
0.0
group Id
OG001
lower Limit
0.6
upper Limit
3.8
value
1.5
title
Rash acneiform

denoms

counts
group Id
OG000
value
279
group Id
OG001
value
268
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
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 and had follow-up data at or after day 91 from start of radiation therapy

reporting Status

POSTED

time Frame

From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years.

title

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

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice