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NCT01302834 · OUTCOME

Percentage of Participants With a Feeding Tube at 1 Year

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 1 year.

Analysis population: Eligible patients who started study treatment and had feeding tube assessment at 1 year

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 + Cisplatin368
IMRT + Cetuximab356

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin9.2Not reported6.512.7Not reported
IMRT + Cetuximab8.4Not reported5.811.8Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.79
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.79
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.5
        upper Limit
        12.7
        value
        9.2
      2. group Id
        OG001
        lower Limit
        5.8
        upper Limit
        11.8
        value
        8.4
denoms
  1. counts
    1. group Id
      OG000
      value
      368
    2. group Id
      OG001
      value
      356
    units
    Participants
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 patients who started study treatment and had feeding tube assessment at 1 year
reporting Status
POSTED
time Frame
From randomization to 1 year.
title
Percentage of Participants With a Feeding Tube at 1 Year
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice