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NCT00956007 · OUTCOME

Disease-free Survival

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 LRR, DM, death or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 12.1 years.

What was measured

Disease is defined as local-regional progression/recurrence (LRR) or distant metastasis (DM). LRR is defined as recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; both imaging and biopsy confirmation are strongly recommended. DM is defined as clear evidence of distant metastases; biopsy is recommended where possible. Disease-free survival time is defined as time from randomization to the date of first disease, death, or last known follow-up (censored), whichever occurred first. Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of disease-free survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.

Analysis population: Randomized eligible participants

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT63.6Not reported57.869.3Not reported
IMRT Plus Cetuximab71.7Not reported66.377.1Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.98
    estimate Comment
    Stratified by EGFR and site/p16 status. Reference level = IMRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0168
    p Value Comment
    One-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Comment
    Stratified by EGFR and site/p16 status
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.98
    estimate Comment
    Stratified by EGFR and site/p16 status. Reference level = IMRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0168
    p Value Comment
    One-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Comment
    Stratified by EGFR and site/p16 status
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.8
        upper Limit
        69.3
        value
        63.6
      2. group Id
        OG001
        lower Limit
        66.3
        upper Limit
        77.1
        value
        71.7
denoms
  1. counts
    1. group Id
      OG000
      value
      287
    2. group Id
      OG001
      value
      290
    units
    Participants
description
Disease is defined as local-regional progression/recurrence (LRR) or distant metastasis (DM). LRR is defined as recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; both imaging and biopsy confirmation are strongly recommended. DM is defined as clear evidence of distant metastases; biopsy is recommended where possible. Disease-free survival time is defined as time from randomization to the date of first disease, death, or last known follow-up (censored), whichever occurred first. Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of disease-free 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
reporting Status
POSTED
time Frame
From randomization to date of LRR, DM, death or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 12.1 years.
title
Disease-free Survival
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice