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NCT00033631 · OUTCOME

Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline and 12 months from randomization

What was measured

The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM.

Analysis population: Eligible participants with baseline and 12 month SQLI

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 Gy547
79.2 Gy517

Reported measurements

Source class 1

Improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
70.2 Gy91Not reportedNot reportedNot reportedNot reported
79.2 Gy91Not reportedNot reportedNot reportedNot reported

Stable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
70.2 Gy366Not reportedNot reportedNot reportedNot reported
79.2 Gy331Not reportedNot reportedNot reportedNot reported

Declined

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
70.2 Gy90Not reportedNot reportedNot reportedNot reported
79.2 Gy95Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.59
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.59
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        91
      title
      Improved
    2. measurements
      1. group Id
        OG000
        value
        366
      2. group Id
        OG001
        value
        331
      title
      Stable
    3. measurements
      1. group Id
        OG000
        value
        90
      2. group Id
        OG001
        value
        95
      title
      Declined
denoms
  1. counts
    1. group Id
      OG000
      value
      547
    2. group Id
      OG001
      value
      517
    units
    Participants
description
The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM.
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
COUNT_OF_PARTICIPANTS
population Description
Eligible participants with baseline and 12 month SQLI
reporting Status
POSTED
time Frame
Baseline and 12 months from randomization
title
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice