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NCT00820248 · OUTCOME

Overall Survival Rate

Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer · Source last updated 2023-08-22

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6.2 years

What was measured

Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported.

Groups in this outcome

Cisplatin

Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy

Panitumumab

Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy

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

Analysis denominator · Participants

GroupSource count
Cisplatin160
Panitumumab160

Reported measurements

Source class 1

Death

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin43Not reportedNot reportedNot reportedNot reported
Panitumumab32Not reportedNot reportedNot reportedNot reported

Alive

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin117Not reportedNot reportedNot reportedNot reported
Panitumumab128Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.48
    estimate Comment
    hazard ratio for panitumumab vs cisplatin
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.66
    param Type
    Cox Proportional Hazard
    param Value
    0.89
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.48
    estimate Comment
    hazard ratio for panitumumab vs cisplatin
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.66
    param Type
    Cox Proportional Hazard
    param Value
    0.89
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        32
      title
      Death
    2. measurements
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        128
      title
      Alive
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      160
    units
    Participants
description
Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported.
groups
  1. description
    Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
    id
    OG000
    title
    Cisplatin
  2. description
    Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
    id
    OG001
    title
    Panitumumab
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
6.2 years
title
Overall Survival Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice