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NCT01084083 · OUTCOME

24-months Overall Survival

Induction Chemotherapy Followed By Cetuximab and Radiation in HPV-Associated Resectable Stage III/IV Oropharynx Cancer · Source last updated 2023-06-28

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
assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry

What was measured

OS was defined as the time from registration to death, or censored at last date known alive. Kaplan-Meier method was used to estimate the overall survival rate at 24 months.

Analysis population: eligible and treated patients

Groups in this outcome

Eligible and Treated Patients

Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT 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
Eligible and Treated Patients80

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Eligible and Treated Patients91Not reported8296Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82
        upper Limit
        96
        value
        91
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
description
OS was defined as the time from registration to death, or censored at last date known alive. Kaplan-Meier method was used to estimate the overall survival rate at 24 months.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
    id
    OG000
    title
    Eligible and Treated Patients
param Type
NUMBER
population Description
eligible and treated patients
reporting Status
POSTED
time Frame
assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry
title
24-months Overall Survival
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice