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NCT00265941 · OUTCOME

Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2022-06-14

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
3 months and 12 months

What was measured

The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete.

Analysis population: Randomized eligible patients with PSS-HN data at the given time point.

Groups in this outcome

RT + Cisplatin

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin

RT + Cisplatin + Cetuximab

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus 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 + Cisplatin447
RT + Cisplatin + Cetuximab444

Reported measurements

Normalcy of Diet 3 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin282
RT + Cisplatin + Cetuximab272
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.80Not reported0.750.84Not reported
RT + Cisplatin + Cetuximab0.85Not reported0.800.89Not reported
Normalcy of Diet 12 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin234
RT + Cisplatin + Cetuximab223
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.37Not reported0.310.43Not reported
RT + Cisplatin + Cetuximab0.37Not reported0.310.44Not reported
Public Eating 3 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin283
RT + Cisplatin + Cetuximab272
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.62Not reported0.560.67Not reported
RT + Cisplatin + Cetuximab0.63Not reported0.590.67Not reported
Public Eating 12 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin234
RT + Cisplatin + Cetuximab230
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.18Not reported0.130.23Not reported
RT + Cisplatin + Cetuximab0.23Not reported0.180.28Not reported
Understandability of Speech 3 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin294
RT + Cisplatin + Cetuximab277
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.09Not reported0.060.12Not reported
RT + Cisplatin + Cetuximab0.08Not reported0.050.12Not reported
Understandability of Speech 12 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin238
RT + Cisplatin + Cetuximab231
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.05Not reported0.020.08Not reported
RT + Cisplatin + Cetuximab0.04Not reported0.020.07Not reported

Source statistical analyses

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

  1. group Description
    Diet 3-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.13
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  2. group Description
    Diet 12-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.87
    statistical Comment
    2-sided significance level 0.05
    statistical Method
    Chi-squared
  3. group Description
    Eating 3-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.39
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  4. group Description
    Eating 12-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.16
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  5. group Description
    Speech 3-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.81
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  6. group Description
    Speech 12-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.67
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    Diet 3-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.13
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  2. group Description
    Diet 12-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.87
    statistical Comment
    2-sided significance level 0.05
    statistical Method
    Chi-squared
  3. group Description
    Eating 3-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.39
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  4. group Description
    Eating 12-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.16
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  5. group Description
    Speech 3-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.81
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
  6. group Description
    Speech 12-month
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.67
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.75
        upper Limit
        0.84
        value
        0.80
      2. group Id
        OG001
        lower Limit
        0.80
        upper Limit
        0.89
        value
        0.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        282
      2. group Id
        OG001
        value
        272
      units
      Participants
    title
    Normalcy of Diet 3 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.31
        upper Limit
        0.43
        value
        0.37
      2. group Id
        OG001
        lower Limit
        0.31
        upper Limit
        0.44
        value
        0.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        234
      2. group Id
        OG001
        value
        223
      units
      Participants
    title
    Normalcy of Diet 12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.56
        upper Limit
        0.67
        value
        0.62
      2. group Id
        OG001
        lower Limit
        0.59
        upper Limit
        0.67
        value
        0.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        283
      2. group Id
        OG001
        value
        272
      units
      Participants
    title
    Public Eating 3 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.13
        upper Limit
        0.23
        value
        0.18
      2. group Id
        OG001
        lower Limit
        0.18
        upper Limit
        0.28
        value
        0.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        234
      2. group Id
        OG001
        value
        230
      units
      Participants
    title
    Public Eating 12 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.06
        upper Limit
        0.12
        value
        0.09
      2. group Id
        OG001
        lower Limit
        0.05
        upper Limit
        0.12
        value
        0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        294
      2. group Id
        OG001
        value
        277
      units
      Participants
    title
    Understandability of Speech 3 months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.02
        upper Limit
        0.08
        value
        0.05
      2. group Id
        OG001
        lower Limit
        0.02
        upper Limit
        0.07
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        238
      2. group Id
        OG001
        value
        231
      units
      Participants
    title
    Understandability of Speech 12 months
denoms
  1. counts
    1. group Id
      OG000
      value
      447
    2. group Id
      OG001
      value
      444
    units
    Participants
description
The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
    id
    OG000
    title
    RT + Cisplatin
  2. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
    id
    OG001
    title
    RT + Cisplatin + Cetuximab
param Type
NUMBER
population Description
Randomized eligible patients with PSS-HN data at the given time point.
reporting Status
POSTED
time Frame
3 months and 12 months
title
Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice