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NCT00047008 · OUTCOME

Disease-free Survival (Percentage of Participants Alive Without Disease)

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. Three-year rates are reported here.

What was measured

Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Fractionation RT + Cisplatin51.4Not reported46.356.6Not reported
Accelerated Fractionation RT + Cisplatin53.4Not reported48.258.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.42
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.99
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.42
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.99
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.3
        upper Limit
        56.6
        value
        51.4
      2. group Id
        OG001
        lower Limit
        48.2
        upper Limit
        58.6
        value
        53.4
denoms
  1. counts
    1. group Id
      OG000
      value
      361
    2. group Id
      OG001
      value
      360
    units
    Participants
description
Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
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. Three-year rates are reported here.
title
Disease-free Survival (Percentage of Participants Alive Without Disease)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice