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NCT01302834 · OUTCOME

Overall Survival by Sex

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer · Source last updated 2026-07-20

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
From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

What was measured

NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.

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

Groups in this outcome

IMRT + Cisplatin

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

IMRT + Cetuximab

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin406
IMRT + Cetuximab399

Reported measurements

Female

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin33
IMRT + Cetuximab44
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin93.4Not reported84.6100Not reported
IMRT + Cetuximab76.8Not reported62.890.8Not reported
Male

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin373
IMRT + Cetuximab355
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin83.8Not reported79.688.1Not reported
IMRT + Cetuximab78.0Not reported73.282.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        84.6
        upper Limit
        100
        value
        93.4
      2. group Id
        OG001
        lower Limit
        62.8
        upper Limit
        90.8
        value
        76.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        44
      units
      Participants
    title
    Female
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        79.6
        upper Limit
        88.1
        value
        83.8
      2. group Id
        OG001
        lower Limit
        73.2
        upper Limit
        82.9
        value
        78.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        373
      2. group Id
        OG001
        value
        355
      units
      Participants
    title
    Male
denoms
  1. counts
    1. group Id
      OG000
      value
      406
    2. group Id
      OG001
      value
      399
    units
    Participants
description
NIH-required analysis. An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
dispersion Type
95% Confidence Interval
groups
  1. description
    Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
    id
    OG000
    title
    IMRT + Cisplatin
  2. description
    Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
    id
    OG001
    title
    IMRT + Cetuximab
param Type
NUMBER
population Description
Eligible participants. Data were stratified by sex.
reporting Status
POSTED
time Frame
From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
title
Overall Survival by Sex
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice