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NCT02254278 · OUTCOME

Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)

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
90% Confidence Interval
Time frame
From randomization to 2 years

What was measured

Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.

Analysis population: Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants.

Groups in this outcome

IMRT 6 Weeks + Cisplatin (Arm 1)

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 (Arm 2)

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 + Cisplatin (Arm 1)147
IMRT 5 Weeks (Arm 2)145

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT 6 Weeks + Cisplatin (Arm 1)90.5Not reported86.6Not reportedone-side confidence interval
IMRT 5 Weeks (Arm 2)87.6Not reported83.3Not reportedone-side confidence interval

Source statistical analyses

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

  1. group Description
    Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.04
    statistical Comment
    One-sided significance level=0.10
    statistical Method
    binomial
  2. group Description
    Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.23
    statistical Comment
    One-sided significance level = 0.10
    statistical Method
    bionmial
Complete source fields
analyses
  1. group Description
    Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.04
    statistical Comment
    One-sided significance level=0.10
    statistical Method
    binomial
  2. group Description
    Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.23
    statistical Comment
    One-sided significance level = 0.10
    statistical Method
    bionmial
classes
  1. categories
    1. measurements
      1. comment
        one-side confidence interval
        group Id
        OG000
        lower Limit
        86.6
        value
        90.5
      2. comment
        one-side confidence interval
        group Id
        OG001
        lower Limit
        83.3
        value
        87.6
denoms
  1. counts
    1. group Id
      OG000
      value
      147
    2. group Id
      OG001
      value
      145
    units
    Participants
description
Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.
dispersion Type
90% 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 (Arm 1)
  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 (Arm 2)
param Type
NUMBER
population Description
Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants.
reporting Status
POSTED
time Frame
From randomization to 2 years
title
Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice