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NCT02254278 · OUTCOME

Percentage of Participants With Distant Metastasis

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

Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of 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 + Cisplatin0Not reported00Not reported
IMRT 5 Weeks0Not reported00Not reported
Two years
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT 6 Weeks + Cisplatin4.0Not reported1.68.0Not reported
IMRT 5 Weeks2.1Not reported0.65.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.08
    estimate Comment
    Reference level = IMRT 5 weeks
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.58
    param Type
    Hazard Ratio (HR)
    param Value
    1.43
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.08
    estimate Comment
    Reference level = IMRT 5 weeks
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.58
    param Type
    Hazard Ratio (HR)
    param Value
    1.43
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    Six months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.6
        upper Limit
        8.0
        value
        4.0
      2. group Id
        OG001
        lower Limit
        0.6
        upper Limit
        5.5
        value
        2.1
    title
    Two years
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      149
    units
    Participants
description
Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of 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 Distant Metastasis
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice