NCT01196390 · OUTCOME

Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment

Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer · Source last updated 2026-06-02

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: Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start

What was measured

The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points.

Analysis population: Eligible participants who consented to quality of life evaluation and who had baseline and time point data.

Groups in this outcome

Chemoradiation and Trastuzumab

Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab

Chemoradiation

Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery

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
Chemoradiation and Trastuzumab	88
Chemoradiation	83

Reported measurements

6-8 weeks from end of treatment

Analysis denominator · Participants

Group	Source count
Chemoradiation and Trastuzumab	48
Chemoradiation	56

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Chemoradiation and Trastuzumab	46	Not reported	33	60	Not reported
Chemoradiation	38	Not reported	26	51	Not reported

1 year from start of treatment

Analysis denominator · Participants

Group	Source count
Chemoradiation and Trastuzumab	44
Chemoradiation	36

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Chemoradiation and Trastuzumab	39	Not reported	26	53	Not reported
Chemoradiation	42	Not reported	27	58	Not reported

2 years from start of treatment

Analysis denominator · Participants

Group	Source count
Chemoradiation and Trastuzumab	22
Chemoradiation	30

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Chemoradiation and Trastuzumab	41	Not reported	23	61	Not reported
Chemoradiation	27	Not reported	14	45	Not reported

Source statistical analyses

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

group Description
6-8 weeks
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.39
p Value Comment
One-side significance level = 0.05
statistical Method
Chi-squared
group Description
1 year
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.78
p Value Comment
One-side significance level = 0.05
statistical Method
Chi-squared
group Description
2 years
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.28
p Value Comment
One-side significance level = 0.05
statistical Method
Chi-squared

Complete source fields

analyses

group Description
6-8 weeks
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.39
p Value Comment
One-side significance level = 0.05
statistical Method
Chi-squared
group Description
1 year
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.78
p Value Comment
One-side significance level = 0.05
statistical Method
Chi-squared
group Description
2 years
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.28
p Value Comment
One-side significance level = 0.05
statistical Method
Chi-squared

classes

categories
measurements
group Id
OG000
lower Limit
33
upper Limit
60
value
46
group Id
OG001
lower Limit
26
upper Limit
51
value
38
denoms
counts
group Id
OG000
value
48
group Id
OG001
value
56
units
Participants
title
6-8 weeks from end of treatment
categories
measurements
group Id
OG000
lower Limit
26
upper Limit
53
value
39
group Id
OG001
lower Limit
27
upper Limit
58
value
42
denoms
counts
group Id
OG000
value
44
group Id
OG001
value
36
units
Participants
title
1 year from start of treatment
categories
measurements
group Id
OG000
lower Limit
23
upper Limit
61
value
41
group Id
OG001
lower Limit
14
upper Limit
45
value
27
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
30
units
Participants
title
2 years from start of treatment

denoms

counts
group Id
OG000
value
88
group Id
OG001
value
83
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
id
OG000
title
Chemoradiation and Trastuzumab
description
Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
id
OG001
title
Chemoradiation

param Type

NUMBER

population Description

Eligible participants who consented to quality of life evaluation and who had baseline and time point data.

reporting Status

POSTED

time Frame

Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start

title

Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice