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NCT02254278 · OUTCOME

HPV DNA Status by 2-year Progression-free Survival Status

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From end of treatment (approximate 6 weeks) to 2 years

What was measured

Progression-free survival (PFS) failure is defined as local, regional, or distant disease progression or death due to any cause. Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.

Analysis population: Eligible participants with post-treatment HPV DNA value and two-year progression-free survival data (i.e. not censored)

Groups in this outcome

PFS Failure at 2 Years = No

Treatment arms are combined: MRT 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

PFS Failure at 2 Years = Yes

Treatment arms are combined: MRT 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
PFS Failure at 2 Years = No117
PFS Failure at 2 Years = Yes11

Reported measurements

Source class 1

HPV DNA Negative

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PFS Failure at 2 Years = No112Not reportedNot reportedNot reportedNot reported
PFS Failure at 2 Years = Yes8Not reportedNot reportedNot reportedNot reported

HPV DNA Positive

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PFS Failure at 2 Years = No5Not reportedNot reportedNot reportedNot reported
PFS Failure at 2 Years = Yes3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.02
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.02
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        112
      2. group Id
        OG001
        value
        8
      title
      HPV DNA Negative
    2. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      title
      HPV DNA Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Progression-free survival (PFS) failure is defined as local, regional, or distant disease progression or death due to any cause. Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.
groups
  1. description
    Treatment arms are combined: MRT 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
    PFS Failure at 2 Years = No
  2. description
    Treatment arms are combined: MRT 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
    OG001
    title
    PFS Failure at 2 Years = Yes
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible participants with post-treatment HPV DNA value and two-year progression-free survival data (i.e. not censored)
reporting Status
POSTED
time Frame
From end of treatment (approximate 6 weeks) to 2 years
title
HPV DNA Status by 2-year Progression-free Survival Status
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice