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NCT01196390 · OUTCOME

Disease-free Survival (DFS) by Sex

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 8.0 years.

What was measured

NIH-required analysis. A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.

Analysis population: Eligible randomized participants. Data were stratified by sex.

Groups in this outcome

Chemoradiation and Trastuzumab (Arm 1)

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

Chemoradiation (Arm 2)

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 Trastuzumab (Arm 1)98
Chemoradiation (Arm 2)96

Reported measurements

Female

Analysis denominator · Participants

GroupSource count
Chemoradiation and Trastuzumab (Arm 1)13
Chemoradiation (Arm 2)17
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiation and Trastuzumab (Arm 1)20.8Not reported13.1NAThe upper confidence bound could not be estimated because there were insufficient events beyond the median survival time.
Chemoradiation (Arm 2)18.9Not reported7.7NAThe upper confidence bound could not be estimated because there were insufficient events beyond the median survival time.
Male

Analysis denominator · Participants

GroupSource count
Chemoradiation and Trastuzumab (Arm 1)85
Chemoradiation (Arm 2)79
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiation and Trastuzumab (Arm 1)17.1Not reported11.026.2Not reported
Chemoradiation (Arm 2)13.6Not reported10.324.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper confidence bound could not be estimated because there were insufficient events beyond the median survival time.
        group Id
        OG000
        lower Limit
        13.1
        upper Limit
        NA
        value
        20.8
      2. comment
        The upper confidence bound could not be estimated because there were insufficient events beyond the median survival time.
        group Id
        OG001
        lower Limit
        7.7
        upper Limit
        NA
        value
        18.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Female
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.0
        upper Limit
        26.2
        value
        17.1
      2. group Id
        OG001
        lower Limit
        10.3
        upper Limit
        24.1
        value
        13.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      2. group Id
        OG001
        value
        79
      units
      Participants
    title
    Male
denoms
  1. counts
    1. group Id
      OG000
      value
      98
    2. group Id
      OG001
      value
      96
    units
    Participants
description
NIH-required analysis. A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events 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 (Arm 1)
  2. description
    Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
    id
    OG001
    title
    Chemoradiation (Arm 2)
param Type
MEDIAN
population Description
Eligible randomized participants. Data were stratified by sex.
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.
title
Disease-free Survival (DFS) by Sex
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice