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NCT00084318 · OUTCOME

Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck · Source last updated 2018-12-12

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 start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.

What was measured

Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was \>30%. \[RTOG = Radiation Therapy Oncology Group\]

Analysis population: Eligible patients who started protocol treatment and did not withdraw consent

Groups in this outcome

RT+Cisplatin+Cetuximab

Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.

RT+Docetaxel+Cetuximab

Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.

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

Analysis denominator · Participants

GroupSource count
RT+Cisplatin+Cetuximab97
RT+Docetaxel+Cetuximab106

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT+Cisplatin+Cetuximab9.3Not reported3.515.1Not reported
RT+Docetaxel+Cetuximab12.3Not reported6.018.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.5
        upper Limit
        15.1
        value
        9.3
      2. group Id
        OG001
        lower Limit
        6.0
        upper Limit
        18.5
        value
        12.3
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    2. group Id
      OG001
      value
      106
    units
    Participants
description
Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was \>30%. \[RTOG = Radiation Therapy Oncology Group\]
dispersion Type
95% Confidence Interval
groups
  1. description
    Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
    id
    OG000
    title
    RT+Cisplatin+Cetuximab
  2. description
    Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
    id
    OG001
    title
    RT+Docetaxel+Cetuximab
param Type
NUMBER
population Description
Eligible patients who started protocol treatment and did not withdraw consent
reporting Status
POSTED
time Frame
From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.
title
Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice