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NCT01302834 · OUTCOME

Distribution of First Progression Events

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer · Source last updated 2026-07-20

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 randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.

What was measured

The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."

Analysis population: Eligible participants with progression-free survival failure

Groups in this outcome

IMRT + Cisplatin

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

IMRT + Cetuximab

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 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 + Cisplatin76
IMRT + Cetuximab122

Reported measurements

Local
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin13Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab25Not reportedNot reportedNot reportedNot reported
Regional
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin6Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab14Not reportedNot reportedNot reportedNot reported
Local and regional
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin4Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab8Not reportedNot reportedNot reportedNot reported
Local and distant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin0Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab1Not reportedNot reportedNot reportedNot reported
Regional and distant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin0Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab5Not reportedNot reportedNot reportedNot reported
Local, regional, and distant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin0Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab2Not reportedNot reportedNot reportedNot reported
Distant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin31Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab43Not reportedNot reportedNot reportedNot reported
Death, due to this disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin2Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab0Not reportedNot reportedNot reportedNot reported
Death, due to second primary
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin1Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab3Not reportedNot reportedNot reportedNot reported
Death, due to other reason
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin10Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab11Not reportedNot reportedNot reportedNot reported
Death, due to unknown reason
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMRT + Cisplatin9Not reportedNot reportedNot reportedNot reported
IMRT + Cetuximab10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        25
    title
    Local
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        14
    title
    Regional
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        8
    title
    Local and regional
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Local and distant
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
    title
    Regional and distant
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Local, regional, and distant
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        43
    title
    Distant
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Death, due to this disease
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Death, due to second primary
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        11
    title
    Death, due to other reason
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        10
    title
    Death, due to unknown reason
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      122
    units
    Participants
description
The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."
groups
  1. description
    Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
    id
    OG000
    title
    IMRT + Cisplatin
  2. description
    Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
    id
    OG001
    title
    IMRT + Cetuximab
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible participants with progression-free survival failure
reporting Status
POSTED
time Frame
From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
title
Distribution of First Progression Events
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice