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NCT00033631 · OUTCOME

Local Progression

Radiation Therapy in Treating Patients With Stage II Prostate Cancer · Source last updated 2023-01-18

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 date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.

What was measured

Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.

Analysis population: All eligible patients who have not withdrawn consent

Groups in this outcome

70.2 Gy

70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.

79.2 Gy

79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 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
70.2 Gy751
79.2 Gy748

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
70.2 Gy3.5Not reported2.35Not reported
79.2 Gy1.8Not reported13Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    Reference level = 70.2 Gy arm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.41
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Gray's test
Complete source fields
analyses
  1. ci Lower Limit
    0.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    Reference level = 70.2 Gy arm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.41
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Gray's test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.3
        upper Limit
        5
        value
        3.5
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        3
        value
        1.8
denoms
  1. counts
    1. group Id
      OG000
      value
      751
    2. group Id
      OG001
      value
      748
    units
    Participants
description
Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    id
    OG000
    title
    70.2 Gy
  2. description
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    id
    OG001
    title
    79.2 Gy
param Type
NUMBER
population Description
All eligible patients who have not withdrawn consent
reporting Status
POSTED
time Frame
From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
title
Local Progression
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice