Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00820248 · OUTCOME

Progression-free Survival (PFS) 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

The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, \> 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event 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

PFS event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin50Not reportedNot reportedNot reportedNot reported
Panitumumab43Not reportedNot reportedNot reportedNot reported

no PFS event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin110Not reportedNot reportedNot reportedNot reported
Panitumumab117Not 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
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.50
    estimate Comment
    Hazard ratio of panitumumab vs cisplatin
    group Description
    The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.83
    param Type
    Hazard Ratio (HR)
    param Value
    0.95
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.50
    estimate Comment
    Hazard ratio of panitumumab vs cisplatin
    group Description
    The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.83
    param Type
    Hazard Ratio (HR)
    param Value
    0.95
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        43
      title
      PFS event
    2. measurements
      1. group Id
        OG000
        value
        110
      2. group Id
        OG001
        value
        117
      title
      no PFS event
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      160
    units
    Participants
description
The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, \> 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event 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
Progression-free Survival (PFS) Rate
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice