NCT00956007 · BASELINE

Baseline characteristics

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.

denoms

counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants

groups

description
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
id
BG000
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
BG001
title
IMRT Plus Cetuximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
27
upper Limit
80
value
57
group Id
BG001
lower Limit
20
upper Limit
79
value
57.5
group Id
BG002
lower Limit
20
upper Limit
80
value
57
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
62
group Id
BG001
value
71
group Id
BG002
value
133
title
≤ 49 years
measurements
group Id
BG000
value
111
group Id
BG001
value
95
group Id
BG002
value
206
title
50 - 59 years
measurements
group Id
BG000
value
91
group Id
BG001
value
101
group Id
BG002
value
192
title
60 - 69 years
measurements
group Id
BG000
value
23
group Id
BG001
value
23
group Id
BG002
value
46
title
≥ 70 years
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
83
group Id
BG001
value
90
group Id
BG002
value
173
title
Female
measurements
group Id
BG000
value
204
group Id
BG001
value
200
group Id
BG002
value
404
title
Male
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
22
group Id
BG001
value
16
group Id
BG002
value
38
title
Hispanic or Latino
measurements
group Id
BG000
value
256
group Id
BG001
value
268
group Id
BG002
value
524
title
Not Hispanic or Latino
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
American Indian or Alaska Native
measurements
group Id
BG000
value
8
group Id
BG001
value
12
group Id
BG002
value
20
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
21
group Id
BG001
value
21
group Id
BG002
value
42
title
Black or African American
measurements
group Id
BG000
value
249
group Id
BG001
value
249
group Id
BG002
value
498
title
White
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
More than one race
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
134
group Id
BG001
value
152
group Id
BG002
value
286
title
0
measurements
group Id
BG000
value
153
group Id
BG001
value
138
group Id
BG002
value
291
title
1
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
description
0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \<50% in bed during the day; 3 = Symptomatic, \>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death
param Type
COUNT_OF_PARTICIPANTS
title
Zubrod performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
92
group Id
BG001
value
110
group Id
BG002
value
202
title
Never
measurements
group Id
BG000
value
173
group Id
BG001
value
160
group Id
BG002
value
333
title
Former
measurements
group Id
BG000
value
21
group Id
BG001
value
18
group Id
BG002
value
39
title
Current
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Unknown
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Smoking history
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
152
group Id
BG002
value
291
title
≤ 10
measurements
group Id
BG000
value
112
group Id
BG001
value
107
group Id
BG002
value
219
title
> 10
denoms
counts
group Id
BG000
value
251
group Id
BG001
value
259
group Id
BG002
value
510
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Randomized eligible participants with data
title
Smoking history: pack-years
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
129
group Id
BG001
value
146
group Id
BG002
value
275
title
Intensity-modulated radiation therapy (IMRT)
measurements
group Id
BG000
value
153
group Id
BG001
value
128
group Id
BG002
value
281
title
IMRT+ image-guided radiation therapy (IGRT)
measurements
group Id
BG000
value
5
group Id
BG001
value
16
group Id
BG002
value
21
title
None
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Type of radiation therapy
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
246
group Id
BG001
value
242
group Id
BG002
value
488
title
High (≥ 80% of cells positive)
measurements
group Id
BG000
value
38
group Id
BG001
value
44
group Id
BG002
value
82
title
Low (< 80% of cells positive)
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Not evaluable
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
EGFR expression
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
183
group Id
BG001
value
184
group Id
BG002
value
367
title
Oral cavity
measurements
group Id
BG000
value
44
group Id
BG001
value
38
group Id
BG002
value
82
title
Larynx
measurements
group Id
BG000
value
50
group Id
BG001
value
55
group Id
BG002
value
105
title
Oropharynx, p16-positive
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
14
title
Oropharynx, p16-negative
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Oropharynx, p16 unknown
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Primary site
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
55
group Id
BG002
value
109
title
T1
measurements
group Id
BG000
value
120
group Id
BG001
value
116
group Id
BG002
value
236
title
T2
measurements
group Id
BG000
value
42
group Id
BG001
value
51
group Id
BG002
value
93
title
T3
measurements
group Id
BG000
value
71
group Id
BG001
value
68
group Id
BG002
value
139
title
T4a
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
description
Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
param Type
COUNT_OF_PARTICIPANTS
title
Pathologic T stage
unit Of Measure
Participants

population Description

Randomized eligible participants

Complete source fields

denoms

counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants

groups

description
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
id
BG000
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
BG001
title
IMRT Plus Cetuximab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
27
upper Limit
80
value
57
group Id
BG001
lower Limit
20
upper Limit
79
value
57.5
group Id
BG002
lower Limit
20
upper Limit
80
value
57
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
62
group Id
BG001
value
71
group Id
BG002
value
133
title
≤ 49 years
measurements
group Id
BG000
value
111
group Id
BG001
value
95
group Id
BG002
value
206
title
50 - 59 years
measurements
group Id
BG000
value
91
group Id
BG001
value
101
group Id
BG002
value
192
title
60 - 69 years
measurements
group Id
BG000
value
23
group Id
BG001
value
23
group Id
BG002
value
46
title
≥ 70 years
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
83
group Id
BG001
value
90
group Id
BG002
value
173
title
Female
measurements
group Id
BG000
value
204
group Id
BG001
value
200
group Id
BG002
value
404
title
Male
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
22
group Id
BG001
value
16
group Id
BG002
value
38
title
Hispanic or Latino
measurements
group Id
BG000
value
256
group Id
BG001
value
268
group Id
BG002
value
524
title
Not Hispanic or Latino
measurements
group Id
BG000
value
9
group Id
BG001
value
6
group Id
BG002
value
15
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
American Indian or Alaska Native
measurements
group Id
BG000
value
8
group Id
BG001
value
12
group Id
BG002
value
20
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
21
group Id
BG001
value
21
group Id
BG002
value
42
title
Black or African American
measurements
group Id
BG000
value
249
group Id
BG001
value
249
group Id
BG002
value
498
title
White
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
More than one race
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
134
group Id
BG001
value
152
group Id
BG002
value
286
title
0
measurements
group Id
BG000
value
153
group Id
BG001
value
138
group Id
BG002
value
291
title
1
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
description
0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \<50% in bed during the day; 3 = Symptomatic, \>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death
param Type
COUNT_OF_PARTICIPANTS
title
Zubrod performance status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
92
group Id
BG001
value
110
group Id
BG002
value
202
title
Never
measurements
group Id
BG000
value
173
group Id
BG001
value
160
group Id
BG002
value
333
title
Former
measurements
group Id
BG000
value
21
group Id
BG001
value
18
group Id
BG002
value
39
title
Current
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Unknown
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Smoking history
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
152
group Id
BG002
value
291
title
≤ 10
measurements
group Id
BG000
value
112
group Id
BG001
value
107
group Id
BG002
value
219
title
> 10
denoms
counts
group Id
BG000
value
251
group Id
BG001
value
259
group Id
BG002
value
510
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Randomized eligible participants with data
title
Smoking history: pack-years
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
129
group Id
BG001
value
146
group Id
BG002
value
275
title
Intensity-modulated radiation therapy (IMRT)
measurements
group Id
BG000
value
153
group Id
BG001
value
128
group Id
BG002
value
281
title
IMRT+ image-guided radiation therapy (IGRT)
measurements
group Id
BG000
value
5
group Id
BG001
value
16
group Id
BG002
value
21
title
None
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Type of radiation therapy
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
246
group Id
BG001
value
242
group Id
BG002
value
488
title
High (≥ 80% of cells positive)
measurements
group Id
BG000
value
38
group Id
BG001
value
44
group Id
BG002
value
82
title
Low (< 80% of cells positive)
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Not evaluable
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
EGFR expression
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
183
group Id
BG001
value
184
group Id
BG002
value
367
title
Oral cavity
measurements
group Id
BG000
value
44
group Id
BG001
value
38
group Id
BG002
value
82
title
Larynx
measurements
group Id
BG000
value
50
group Id
BG001
value
55
group Id
BG002
value
105
title
Oropharynx, p16-positive
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
14
title
Oropharynx, p16-negative
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Oropharynx, p16 unknown
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Primary site
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
55
group Id
BG002
value
109
title
T1
measurements
group Id
BG000
value
120
group Id
BG001
value
116
group Id
BG002
value
236
title
T2
measurements
group Id
BG000
value
42
group Id
BG001
value
51
group Id
BG002
value
93
title
T3
measurements
group Id
BG000
value
71
group Id
BG001
value
68
group Id
BG002
value
139
title
T4a
denoms
counts
group Id
BG000
value
287
group Id
BG001
value
290
group Id
BG002
value
577
units
Participants
description
Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
param Type
COUNT_OF_PARTICIPANTS
title
Pathologic T stage
unit Of Measure
Participants

population Description

Randomized eligible participants

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Preserved source evidence · Not medical advice