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NCT00956007 · OUTCOME

Percentage of Participants Alive (Overall Survival) by Sex

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

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 sex.

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

Female

Analysis denominator · Participants

GroupSource count
IMRT83
IMRT Plus Cetuximab90
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT75.3Not reported65.884.7Not reported
IMRT Plus Cetuximab72.1Not reported62.481.8Not reported
Male

Analysis denominator · Participants

GroupSource count
IMRT204
IMRT Plus Cetuximab200
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT65.9Not reported59.072.7Not reported
IMRT Plus Cetuximab78.5Not reported72.684.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.8
        upper Limit
        84.7
        value
        75.3
      2. group Id
        OG001
        lower Limit
        62.4
        upper Limit
        81.8
        value
        72.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        90
      units
      Participants
    title
    Female
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.0
        upper Limit
        72.7
        value
        65.9
      2. group Id
        OG001
        lower Limit
        72.6
        upper Limit
        84.4
        value
        78.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        204
      2. group Id
        OG001
        value
        200
      units
      Participants
    title
    Male
denoms
  1. counts
    1. group Id
      OG000
      value
      287
    2. group Id
      OG001
      value
      290
    units
    Participants
description
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 sex.
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 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