Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00047008 · OUTCOME

Overall Survival (Percentage of Participants Alive)

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 patients
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

Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. 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 patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Fractionation RT + Cisplatin64.3Not reported59.369.2Not reported
Accelerated Fractionation RT + Cisplatin70.3Not reported65.675.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.719
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.128
    group Description
    A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.180
    param Type
    Hazard Ratio (HR)
    param Value
    0.90
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.719
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.128
    group Description
    A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.180
    param Type
    Hazard Ratio (HR)
    param Value
    0.90
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.3
        upper Limit
        69.2
        value
        64.3
      2. group Id
        OG001
        lower Limit
        65.6
        upper Limit
        75.1
        value
        70.3
denoms
  1. counts
    1. group Id
      OG000
      value
      361
    2. group Id
      OG001
      value
      360
    units
    Participants
description
Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. 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
Overall Survival (Percentage of Participants Alive)
type
PRIMARY
unit Of Measure
percentage of patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice