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NCT02254278 · OUTCOME

Change in Number of HPV DNA Fragments/mL (Copy Number) From Baseline to During Treatment (HPV DNA Rate Decline)

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
MEAN
Unit
fragments/mL
Interval / dispersion
95% Confidence Interval
Time frame
Baseline and during treatment (obtained after 20 Gy of radiotherapy and before 28 Gy, approximately between day 10 and 14)

What was measured

Calculated as treatment value - baseline value. HPV DNA was assessed by tumor-tissue modified viral (TTMV) testing.

Analysis population: Eligible patients with baseline and during treatment HPV DNA values.

Groups in this outcome

IMRT 6 Weeks + Cisplatin (Arm 1)

Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 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 2)

IMRT 5 weeks: 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
IMRT 6 Weeks + Cisplatin (Arm 1)70
IMRT 5 Weeks (Arm 2)69

Reported measurements

Source class 1
Values in fragments/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT 6 Weeks + Cisplatin (Arm 1)-1.06Not reported-1.68-0.45Not reported
IMRT 5 Weeks (Arm 2)-0.22Not reported-0.680.24Not 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
    0.03
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.03
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.68
        upper Limit
        -0.45
        value
        -1.06
      2. group Id
        OG001
        lower Limit
        -0.68
        upper Limit
        0.24
        value
        -0.22
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    2. group Id
      OG001
      value
      69
    units
    Participants
description
Calculated as treatment value - baseline value. HPV DNA was assessed by tumor-tissue modified viral (TTMV) testing.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 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
    id
    OG000
    title
    IMRT 6 Weeks + Cisplatin (Arm 1)
  2. description
    IMRT 5 weeks: 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
    IMRT 5 Weeks (Arm 2)
param Type
MEAN
population Description
Eligible patients with baseline and during treatment HPV DNA values.
reporting Status
POSTED
time Frame
Baseline and during treatment (obtained after 20 Gy of radiotherapy and before 28 Gy, approximately between day 10 and 14)
title
Change in Number of HPV DNA Fragments/mL (Copy Number) From Baseline to During Treatment (HPV DNA Rate Decline)
type
SECONDARY
unit Of Measure
fragments/mL

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

Preserved source evidence · Not medical advice