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NCT01302834 · OUTCOME

Progression-free Survival by 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

Variant

Has the KRAS variant

Non-variant

Does not have the KRAS variant

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

Analysis denominator · Participants

GroupSource count
Variant92
Non-variant470

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Variant72.0Not reported62.681.3Not reported
Non-variant71.5Not reported67.375.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.38
    estimate Comment
    Reference level = non-variant
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3704
    p Value Comment
    One-sided significance level = 0.05.
    param Type
    Cox Proportional Hazard
    param Value
    0.94
    statistical Comment
    Stratified by treatment arm.
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.38
    estimate Comment
    Reference level = non-variant
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3704
    p Value Comment
    One-sided significance level = 0.05.
    param Type
    Cox Proportional Hazard
    param Value
    0.94
    statistical Comment
    Stratified by treatment arm.
    statistical Method
    Regression, Cox
anticipated Posting Date
2025-12
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.6
        upper Limit
        81.3
        value
        72.0
      2. group Id
        OG001
        lower Limit
        67.3
        upper Limit
        75.7
        value
        71.5
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      470
    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
    Has the KRAS variant
    id
    OG000
    title
    Variant
  2. description
    Does not have the KRAS variant
    id
    OG001
    title
    Non-variant
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 by KRAS Variant Status
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice