Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02254278 · OUTCOME

Percentage of Participants With Local-regional Failure

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer · Source last updated 2026-05-22

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 2 years

What was measured

Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.

Analysis population: Randomized and eligible participants

Groups in this outcome

IMRT 6 Weeks + Cisplatin

Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy

IMRT 5 Weeks

IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 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 6 Weeks + Cisplatin157
IMRT 5 Weeks149

Reported measurements

Six months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT 6 Weeks + Cisplatin0.7Not reported0.13.3Not reported
IMRT 5 Weeks2.0Not reported0.65.4Not reported
Two years
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT 6 Weeks + Cisplatin3.3Not reported1.27.1Not reported
IMRT 5 Weeks9.5Not reported5.515.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    Reference level = IMRT 5 weeks
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.02
    param Type
    Hazard Ratio (HR)
    param Value
    0.39
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    Reference level = IMRT 5 weeks
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.02
    param Type
    Hazard Ratio (HR)
    param Value
    0.39
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        3.3
        value
        0.7
      2. group Id
        OG001
        lower Limit
        0.6
        upper Limit
        5.4
        value
        2.0
    title
    Six months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        7.1
        value
        3.3
      2. group Id
        OG001
        lower Limit
        5.5
        upper Limit
        15.0
        value
        9.5
    title
    Two years
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      149
    units
    Participants
description
Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    id
    OG000
    title
    IMRT 6 Weeks + Cisplatin
  2. description
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    id
    OG001
    title
    IMRT 5 Weeks
param Type
NUMBER
population Description
Randomized and eligible participants
reporting Status
POSTED
time Frame
From randomization to 2 years
title
Percentage of Participants With Local-regional Failure
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice