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NCT02254278 · OUTCOME

Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer · Source last updated 2026-05-22

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
90% Confidence Interval
Time frame
3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)

What was measured

NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.

Analysis population: Randomized and eligible participants with negative post-treatment PET

Groups in this outcome

Both Arms Combined

IMRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy. IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy

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

Analysis denominator · Participants

GroupSource count
Both Arms Combined115

Reported measurements

Progression-free Survival
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Both Arms Combined92.0Not reported87.7Not reportedOne-sided interval
Local-regional failure
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Both Arms Combined94.5Not reported90.6Not reportedOne-side interval

Source statistical analyses

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

  1. group Description
    Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3
    statistical Comment
    One-sided significance level = 0.10
    statistical Method
    binomial test
  2. group Description
    Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.07
    statistical Comment
    One-sided significance level = 0.10
    statistical Method
    binomial test
Complete source fields
analyses
  1. group Description
    Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3
    statistical Comment
    One-sided significance level = 0.10
    statistical Method
    binomial test
  2. group Description
    Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.07
    statistical Comment
    One-sided significance level = 0.10
    statistical Method
    binomial test
classes
  1. categories
    1. measurements
      1. comment
        One-sided interval
        group Id
        OG000
        lower Limit
        87.7
        value
        92.0
    title
    Progression-free Survival
  2. categories
    1. measurements
      1. comment
        One-side interval
        group Id
        OG000
        lower Limit
        90.6
        value
        94.5
    title
    Local-regional failure
denoms
  1. counts
    1. group Id
      OG000
      value
      115
    units
    Participants
description
NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.
dispersion Type
90% Confidence Interval
groups
  1. description
    IMRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy. IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    id
    OG000
    title
    Both Arms Combined
param Type
NUMBER
population Description
Randomized and eligible participants with negative post-treatment PET
reporting Status
POSTED
time Frame
3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)
title
Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice