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NCT01087970 · OUTCOME

Overall Survival (OS)

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2014-05-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)

What was measured

OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.

Analysis population: All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.

Groups in this outcome

Cetuximab + Pemetrexed + Carboplatin/Cisplatin

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

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

Analysis denominator · Participants

GroupSource count
Cetuximab + Pemetrexed + Carboplatin/Cisplatin58

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin11.1Not reported7.614.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.6
        upper Limit
        14.8
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    id
    OG000
    title
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
param Type
MEDIAN
population Description
All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.
reporting Status
POSTED
time Frame
From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice