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NCT01302834 · OUTCOME

Progression-free Survival Within KRAS Variant Status

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 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.

What was measured

KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio 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 with KRAS data

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 + Cisplatin275
IMRT + Cetuximab287

Reported measurements

Variant

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin44
IMRT + Cetuximab48
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin76.6Not reported63.989.3Not reported
IMRT + Cetuximab67.7Not reported54.281.2Not reported
Non-variant

Analysis denominator · Participants

GroupSource count
IMRT + Cisplatin231
IMRT + Cetuximab239
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin75.1Not reported69.480.8Not reported
IMRT + Cetuximab68.0Not reported62.074.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.50
    ci Pct Value
    95
    ci Upper Limit
    2.04
    estimate Comment
    Reference level = IMRT + Cisplatin
    group Description
    Variant
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.01
  2. ci Lower Limit
    0.94
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.73
    estimate Comment
    Reference level = IMRT + Cisplatin
    group Description
    Non-variant
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.27
  3. group Description
    Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.5556
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.50
    ci Pct Value
    95
    ci Upper Limit
    2.04
    estimate Comment
    Reference level = IMRT + Cisplatin
    group Description
    Variant
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.01
  2. ci Lower Limit
    0.94
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.73
    estimate Comment
    Reference level = IMRT + Cisplatin
    group Description
    Non-variant
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.27
  3. group Description
    Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.5556
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63.9
        upper Limit
        89.3
        value
        76.6
      2. group Id
        OG001
        lower Limit
        54.2
        upper Limit
        81.2
        value
        67.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        48
      units
      Participants
    title
    Variant
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.4
        upper Limit
        80.8
        value
        75.1
      2. group Id
        OG001
        lower Limit
        62.0
        upper Limit
        74.1
        value
        68.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        231
      2. group Id
        OG001
        value
        239
      units
      Participants
    title
    Non-variant
denoms
  1. counts
    1. group Id
      OG000
      value
      275
    2. group Id
      OG001
      value
      287
    units
    Participants
description
KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments. An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio 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 with KRAS data
reporting Status
POSTED
time Frame
From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.
title
Progression-free Survival Within KRAS Variant Status
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice