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NCT00047008 · OUTCOME

Percentage of Participants With Toxicity Grade 3 or Higher

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer · Source last updated 2023-07-07

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
95% Confidence Interval
Time frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.

What was measured

Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.

Analysis population: Eligible patients who did not withdraw consent

Groups in this outcome

Standard Fractionation RT + Cisplatin

Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.

Accelerated Fractionation RT + Cisplatin

Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.

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

Analysis denominator · Participants

GroupSource count
Standard Fractionation RT + Cisplatin361
Accelerated Fractionation RT + Cisplatin360

Reported measurements

Acute

Analysis denominator · Participants

GroupSource count
Standard Fractionation RT + Cisplatin361
Accelerated Fractionation RT + Cisplatin360
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Fractionation RT + Cisplatin83.7Not reported79.887.5Not reported
Accelerated Fractionation RT + Cisplatin80.0Not reported75.984.1Not reported
Late

Analysis denominator · Participants

GroupSource count
Standard Fractionation RT + Cisplatin351
Accelerated Fractionation RT + Cisplatin343
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Fractionation RT + Cisplatin21.1Not reported16.825.3Not reported
Accelerated Fractionation RT + Cisplatin25.7Not reported21.030.3Not reported

Source statistical analyses

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

  1. group Description
    Acute toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.21
    p Value Comment
    Two-side significance level = 0.05
    statistical Method
    Fisher Exact
  2. group Description
    Late toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.18
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Acute toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.21
    p Value Comment
    Two-side significance level = 0.05
    statistical Method
    Fisher Exact
  2. group Description
    Late toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.18
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        79.8
        upper Limit
        87.5
        value
        83.7
      2. group Id
        OG001
        lower Limit
        75.9
        upper Limit
        84.1
        value
        80.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        361
      2. group Id
        OG001
        value
        360
      units
      Participants
    title
    Acute
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.8
        upper Limit
        25.3
        value
        21.1
      2. group Id
        OG001
        lower Limit
        21.0
        upper Limit
        30.3
        value
        25.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        351
      2. group Id
        OG001
        value
        343
      units
      Participants
    title
    Late
denoms
  1. counts
    1. group Id
      OG000
      value
      361
    2. group Id
      OG001
      value
      360
    units
    Participants
description
Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
dispersion Type
95% Confidence Interval
groups
  1. description
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    id
    OG000
    title
    Standard Fractionation RT + Cisplatin
  2. description
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    id
    OG001
    title
    Accelerated Fractionation RT + Cisplatin
param Type
NUMBER
population Description
Eligible patients who did not withdraw consent
reporting Status
POSTED
time Frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.
title
Percentage of Participants With Toxicity Grade 3 or Higher
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice