NCT03422198 · BASELINE

Baseline characteristics

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer · Source last updated 2025-12-12

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

denoms

counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants

groups

description
Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
id
BG000
title
Experimental: Short Course Vaginal Cuff Brachytherapy
description
Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
id
BG001
title
Control: Standard of Care Vaginal Cuff Brachytherapy
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
22
group Id
BG001
value
31
group Id
BG002
value
53
title
Between 18 and 65 years
measurements
group Id
BG000
value
32
group Id
BG001
value
23
group Id
BG002
value
55
title
>=65 years
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.25
value
65.31
group Id
BG001
spread
9.68
value
63.65
group Id
BG002
spread
9.95
value
64.48
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
lower Limit
40
upper Limit
84
value
66.5
group Id
BG001
lower Limit
30
upper Limit
87
value
63.5
group Id
BG002
lower Limit
30
upper Limit
87
value
65
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Hispanic or Latino
measurements
group Id
BG000
value
46
group Id
BG001
value
48
group Id
BG002
value
94
title
Not Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
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
1
group Id
BG002
value
1
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
5
group Id
BG001
value
5
group Id
BG002
value
10
title
Black or African American
measurements
group Id
BG000
value
41
group Id
BG001
value
45
group Id
BG002
value
86
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
More than one race
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
21.5
value
72.28
group Id
BG001
spread
21.74
value
67.88
group Id
BG002
spread
21.26
value
70.17
denoms
counts
group Id
BG000
value
52
group Id
BG001
value
48
group Id
BG002
value
100
units
Participants
description
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The quality of life score ranges from 0-100, with higher scores indicating better quality of life.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The primary outcome related to this baseline measure requires participants to have completed both the baseline and Month 1 assessments to be included. Participants without both were excluded in this baseline measure. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Two experimental arm participants did not complete the Month 1 questionnaire.
title
Baseline EORTC Quality of Life Score
unit Of Measure
score on a scale
classes
categories
measurements
group Id
BG000
spread
26.24
value
10.46
group Id
BG001
spread
28.35
value
16.67
group Id
BG002
spread
27.32
value
13.47
denoms
counts
group Id
BG000
value
51
group Id
BG001
value
48
group Id
BG002
value
99
units
Participants
description
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The secondary outcome related to this baseline measure requires participants to have completed both baseline and Month 1 questionnaires to be included. Participants who did not complete both were excluded. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Three experimental arm participants did not complete the Month 1 questionnaire.
title
Baseline EORTC Symptom Score
unit Of Measure
score on a scale

Complete source fields

denoms

counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants

groups

description
Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
id
BG000
title
Experimental: Short Course Vaginal Cuff Brachytherapy
description
Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
id
BG001
title
Control: Standard of Care Vaginal Cuff Brachytherapy
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
22
group Id
BG001
value
31
group Id
BG002
value
53
title
Between 18 and 65 years
measurements
group Id
BG000
value
32
group Id
BG001
value
23
group Id
BG002
value
55
title
>=65 years
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.25
value
65.31
group Id
BG001
spread
9.68
value
63.65
group Id
BG002
spread
9.95
value
64.48
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
lower Limit
40
upper Limit
84
value
66.5
group Id
BG001
lower Limit
30
upper Limit
87
value
63.5
group Id
BG002
lower Limit
30
upper Limit
87
value
65
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
title
Hispanic or Latino
measurements
group Id
BG000
value
46
group Id
BG001
value
48
group Id
BG002
value
94
title
Not Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
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
1
group Id
BG002
value
1
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
5
group Id
BG001
value
5
group Id
BG002
value
10
title
Black or African American
measurements
group Id
BG000
value
41
group Id
BG001
value
45
group Id
BG002
value
86
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
More than one race
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
54
group Id
BG001
value
54
group Id
BG002
value
108
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
21.5
value
72.28
group Id
BG001
spread
21.74
value
67.88
group Id
BG002
spread
21.26
value
70.17
denoms
counts
group Id
BG000
value
52
group Id
BG001
value
48
group Id
BG002
value
100
units
Participants
description
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The quality of life score ranges from 0-100, with higher scores indicating better quality of life.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The primary outcome related to this baseline measure requires participants to have completed both the baseline and Month 1 assessments to be included. Participants without both were excluded in this baseline measure. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Two experimental arm participants did not complete the Month 1 questionnaire.
title
Baseline EORTC Quality of Life Score
unit Of Measure
score on a scale
classes
categories
measurements
group Id
BG000
spread
26.24
value
10.46
group Id
BG001
spread
28.35
value
16.67
group Id
BG002
spread
27.32
value
13.47
denoms
counts
group Id
BG000
value
51
group Id
BG001
value
48
group Id
BG002
value
99
units
Participants
description
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The secondary outcome related to this baseline measure requires participants to have completed both baseline and Month 1 questionnaires to be included. Participants who did not complete both were excluded. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Three experimental arm participants did not complete the Month 1 questionnaire.
title
Baseline EORTC Symptom Score
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice