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NCT00956007 · OUTCOME

Percentage of Participants Alive (Overall Survival) by Race

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer · Source last updated 2026-01-06

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 date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.

What was measured

NIH-required analysis. Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.

Analysis population: Randomized eligible participants. Data were stratified by race.

Groups in this outcome

IMRT

Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).

IMRT Plus Cetuximab

Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.

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

Analysis denominator · Participants

GroupSource count
IMRT287
IMRT Plus Cetuximab290

Reported measurements

American Indian or Alaska Native

Analysis denominator · Participants

GroupSource count
IMRT0
IMRT Plus Cetuximab2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT Plus Cetuximab0Not reportedNANACannot be calculated because the participant was censored prior to the timepoint.
Asian

Analysis denominator · Participants

GroupSource count
IMRT8
IMRT Plus Cetuximab12
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT53.6Not reported14.292.9Not reported
IMRT Plus Cetuximab91.7Not reported76.0100Not reported
Native Hawaiian or Other Pacific Islander

Analysis denominator · Participants

GroupSource count
IMRT1
IMRT Plus Cetuximab0
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT0Not reportedNANACannot be calculated because the participant was censored prior to the timepoint.
Black or African American

Analysis denominator · Participants

GroupSource count
IMRT21
IMRT Plus Cetuximab21
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT57.9Not reported35.780.1Not reported
IMRT Plus Cetuximab69.6Not reported49.390.0Not reported
White

Analysis denominator · Participants

GroupSource count
IMRT249
IMRT Plus Cetuximab249
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT70.1Not reported64.276.0Not reported
IMRT Plus Cetuximab76.8Not reported71.382.3Not reported
More than one race

Analysis denominator · Participants

GroupSource count
IMRT2
IMRT Plus Cetuximab0
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT50.0Not reported0100Not reported
Unknown for Not Reported

Analysis denominator · Participants

GroupSource count
IMRT6
IMRT Plus Cetuximab6
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT83.3Not reported53.5100Not reported
IMRT Plus Cetuximab80.0Not reported44.9100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Cannot be calculated because the participant was censored prior to the timepoint.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0
    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. group Id
        OG000
        lower Limit
        14.2
        upper Limit
        92.9
        value
        53.6
      2. group Id
        OG001
        lower Limit
        76.0
        upper Limit
        100
        value
        91.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Asian
  3. categories
    1. measurements
      1. comment
        Cannot be calculated because the participant was censored prior to the timepoint.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Native Hawaiian or Other Pacific Islander
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.7
        upper Limit
        80.1
        value
        57.9
      2. group Id
        OG001
        lower Limit
        49.3
        upper Limit
        90.0
        value
        69.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    Black or African American
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.2
        upper Limit
        76.0
        value
        70.1
      2. group Id
        OG001
        lower Limit
        71.3
        upper Limit
        82.3
        value
        76.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        249
      2. group Id
        OG001
        value
        249
      units
      Participants
    title
    White
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        100
        value
        50.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    More than one race
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.5
        upper Limit
        100
        value
        83.3
      2. group Id
        OG001
        lower Limit
        44.9
        upper Limit
        100
        value
        80.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Unknown for Not Reported
denoms
  1. counts
    1. group Id
      OG000
      value
      287
    2. group Id
      OG001
      value
      290
    units
    Participants
description
NIH-required analysis. Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
    id
    OG000
    title
    IMRT
  2. description
    Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
    id
    OG001
    title
    IMRT Plus Cetuximab
param Type
NUMBER
population Description
Randomized eligible participants. Data were stratified by race.
reporting Status
POSTED
time Frame
From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
title
Percentage of Participants Alive (Overall Survival) by Race
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice