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NCT01302834 · OUTCOME

Overall Survival by Race

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. Five-year rates are reported here.

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 ethnicity.

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

American Indian or Alaska Native

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin0
IMRT + Cetuximab2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cetuximab100Not reportedNANASAS software does not compute a confidence interval when the estimate is 100%.
Asian

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin2
IMRT + Cetuximab1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + CisplatinNANot reportedNANACannot be calculated because participants was censored prior to the timepoint.
IMRT + Cetuximab100Not reportedNANASAS software does not compute a confidence interval when the estimate is 100%
Native Hawaiian or Other Pacific Islander

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin0
IMRT + Cetuximab2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + CetuximabNANot reportedNANACannot be calculated because participants were censored prior to the timepoint.
Black or African American

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin17
IMRT + Cetuximab19
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin77.5Not reported54.9100Not reported
IMRT + Cetuximab76.4Not reported55.996.9Not reported
White

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin380
IMRT + Cetuximab367
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin84.6Not reported80.588.7Not reported
IMRT + Cetuximab77.3Not reported72.582.1Not reported
More than one race

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin0
IMRT + Cetuximab3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + CetuximabNANot reportedNANACannot be calculated because participants were censored prior to the timepoint.
Unknown or Not Reported

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin7
IMRT + Cetuximab5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin100Not reportedNANASAS software does not compute a confidence interval when the estimate is 100%.
IMRT + Cetuximab100Not reportedNANASAS software does not compute a confidence interval when the estimate is 100%.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        SAS software does not compute a confidence interval when the estimate is 100%.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    American Indian or Alaska Native
  2. categories
    1. measurements
      1. comment
        Cannot be calculated because participants was censored prior to the timepoint.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        SAS software does not compute a confidence interval when the estimate is 100%
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Asian
  3. categories
    1. measurements
      1. comment
        Cannot be calculated because participants were censored prior to the timepoint.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Native Hawaiian or Other Pacific Islander
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.9
        upper Limit
        100
        value
        77.5
      2. group Id
        OG001
        lower Limit
        55.9
        upper Limit
        96.9
        value
        76.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    Black or African American
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80.5
        upper Limit
        88.7
        value
        84.6
      2. group Id
        OG001
        lower Limit
        72.5
        upper Limit
        82.1
        value
        77.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        380
      2. group Id
        OG001
        value
        367
      units
      Participants
    title
    White
  6. categories
    1. measurements
      1. comment
        Cannot be calculated because participants were censored prior to the timepoint.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    More than one race
  7. categories
    1. measurements
      1. comment
        SAS software does not compute a confidence interval when the estimate is 100%.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        100
      2. comment
        SAS software does not compute a confidence interval when the estimate is 100%.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Unknown or Not Reported
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 ethnicity.
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. Five-year rates are reported here.
title
Overall Survival by Race
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice