NCT04162873 · BASELINE

Baseline characteristics

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer · Source last updated 2025-02-12

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

denoms

counts
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
units
Participants

groups

description
Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
id
BG000
title
Celecoxib Arm
description
Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
id
BG001
title
Placebo Arm
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Between 18 and 65 years
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.02
value
60.40
group Id
BG001
spread
20.24
value
65.14
group Id
BG002
spread
15.72
value
63.17
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Female
measurements
group Id
BG000
value
2
group Id
BG001
value
6
group Id
BG002
value
8
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
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
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
11
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Gx
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
G1
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
G2
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
G3
description
Staging systems are utilized in cancer care to standardize the extent of cancer. The TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. With this system, G describes the grade of the cancer. The grade score is based on Differentiation (1-Normal cells to 3-Very abnormal cells), Mitotic count (1 to 3; low score means fewer cells were dividing), and Tumor necrosis (0 to 2; lower score means less dying tissue). This has possible scores of GX (grade cannot be assessed due to incomplete information), G1 (score of 2-3), G2 (score of 4-5), and G3 (score of 6-8).
param Type
COUNT_OF_PARTICIPANTS
title
Initial Histologic Grade
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Stage III
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
8
title
Stage IVA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Stage IVB
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Stage IVC
description
Staging systems are utilized to standardize the extent of cancer, and the TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. The TNM status is tabulated to give a numerical status from Stage I (T1, N0, and M0) to Stage IVC (any T, any N, and M1).
param Type
COUNT_OF_PARTICIPANTS
title
Prognostic Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hypopharynx
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Larynx
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Oral Cavity
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Oropharynx
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Sinonasal
param Type
COUNT_OF_PARTICIPANTS
title
Type of Head and Neck Cancer
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
11
title
Primary
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Recurrent
param Type
COUNT_OF_PARTICIPANTS
title
Primary or Recurrent Tumor
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Right
measurements
group Id
BG000
value
2
group Id
BG001
value
6
group Id
BG002
value
8
title
Left
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Center/Both
param Type
COUNT_OF_PARTICIPANTS
title
Laterality
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
pT1
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
pT3
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
pT4a
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
rpT4a
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
mpT3
description
Staging systems are utilized in cancer care to standardize the extent of the cancer. The TNM (Tumor, Nodes, Metastasized) system is used for bladder cancer. With this system, T describes how far the primary tumor has grown and if it has grown into nearby tissue. This staging system ranges from T0 (No evidence of a primary tumor), T4a (tumor has grown beyond a certain point; moderately advanced), to T4b (tumor has grown further than T4a; very advanced).
param Type
COUNT_OF_PARTICIPANTS
title
Primary Tumor pT
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
units
Participants

groups

description
Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
id
BG000
title
Celecoxib Arm
description
Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
id
BG001
title
Placebo Arm
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Between 18 and 65 years
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.02
value
60.40
group Id
BG001
spread
20.24
value
65.14
group Id
BG002
spread
15.72
value
63.17
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Female
measurements
group Id
BG000
value
2
group Id
BG001
value
6
group Id
BG002
value
8
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
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
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
11
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Gx
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
G1
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
G2
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
G3
description
Staging systems are utilized in cancer care to standardize the extent of cancer. The TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. With this system, G describes the grade of the cancer. The grade score is based on Differentiation (1-Normal cells to 3-Very abnormal cells), Mitotic count (1 to 3; low score means fewer cells were dividing), and Tumor necrosis (0 to 2; lower score means less dying tissue). This has possible scores of GX (grade cannot be assessed due to incomplete information), G1 (score of 2-3), G2 (score of 4-5), and G3 (score of 6-8).
param Type
COUNT_OF_PARTICIPANTS
title
Initial Histologic Grade
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Stage III
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
8
title
Stage IVA
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Stage IVB
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Stage IVC
description
Staging systems are utilized to standardize the extent of cancer, and the TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. The TNM status is tabulated to give a numerical status from Stage I (T1, N0, and M0) to Stage IVC (any T, any N, and M1).
param Type
COUNT_OF_PARTICIPANTS
title
Prognostic Stage
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hypopharynx
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Larynx
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Oral Cavity
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Oropharynx
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Sinonasal
param Type
COUNT_OF_PARTICIPANTS
title
Type of Head and Neck Cancer
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
7
group Id
BG002
value
11
title
Primary
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Recurrent
param Type
COUNT_OF_PARTICIPANTS
title
Primary or Recurrent Tumor
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Right
measurements
group Id
BG000
value
2
group Id
BG001
value
6
group Id
BG002
value
8
title
Left
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Center/Both
param Type
COUNT_OF_PARTICIPANTS
title
Laterality
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
pT1
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
pT3
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
pT4a
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
rpT4a
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
mpT3
description
Staging systems are utilized in cancer care to standardize the extent of the cancer. The TNM (Tumor, Nodes, Metastasized) system is used for bladder cancer. With this system, T describes how far the primary tumor has grown and if it has grown into nearby tissue. This staging system ranges from T0 (No evidence of a primary tumor), T4a (tumor has grown beyond a certain point; moderately advanced), to T4b (tumor has grown further than T4a; very advanced).
param Type
COUNT_OF_PARTICIPANTS
title
Primary Tumor pT
unit Of Measure
Participants

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