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NCT01196390 · OUTCOME

Overall Survival

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.

What was measured

Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.

Analysis population: Eligible randomized participants

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

GroupSource count
Chemoradiation and Trastuzumab98
Chemoradiation96

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiation and Trastuzumab38.5Not reported26.270.4Not reported
Chemoradiation38.9Not reported29.064.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.47
    estimate Comment
    Reference level = Chemoradiation arm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.95
    param Type
    Hazard Ratio (HR)
    param Value
    1.01
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.47
    estimate Comment
    Reference level = Chemoradiation arm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.95
    param Type
    Hazard Ratio (HR)
    param Value
    1.01
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.2
        upper Limit
        70.4
        value
        38.5
      2. group Id
        OG001
        lower Limit
        29.0
        upper Limit
        64.5
        value
        38.9
denoms
  1. counts
    1. group Id
      OG000
      value
      98
    2. group Id
      OG001
      value
      96
    units
    Participants
description
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
    id
    OG000
    title
    Chemoradiation and Trastuzumab
  2. description
    Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
    id
    OG001
    title
    Chemoradiation
param Type
MEDIAN
population Description
Eligible randomized participants
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice