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NCT00750269 · OUTCOME

Progression-free Survival

Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer · Source last updated 2022-06-09

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 death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.

What was measured

Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.

Analysis population: All eligible patients who started study treatment

Groups in this outcome

Level 5: 10.0 Gy/FX

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

Level 6: 10.5 Gy/FX

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

Level 7: 11.0 Gy/FX

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

Level 8: 11.5 Gy/FX

SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

Level 9: 12.0 Gy/FX

SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 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
Level 5: 10.0 Gy/FX8
Level 6: 10.5 Gy/FX7
Level 7: 11.0 Gy/FX14
Level 8: 11.5 Gy/FX38
Level 9: 12.0 Gy/FX33

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Level 5: 10.0 Gy/FX50.0Not reported15.277.5Not reported
Level 6: 10.5 Gy/FX57.1Not reported17.283.7Not reported
Level 7: 11.0 Gy/FX57.1Not reported28.478.0Not reported
Level 8: 11.5 Gy/FX52.2Not reported35.366.6Not reported
Level 9: 12.0 Gy/FX54.5Not reported36.369.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.2
        upper Limit
        77.5
        value
        50.0
      2. group Id
        OG001
        lower Limit
        17.2
        upper Limit
        83.7
        value
        57.1
      3. group Id
        OG002
        lower Limit
        28.4
        upper Limit
        78.0
        value
        57.1
      4. group Id
        OG003
        lower Limit
        35.3
        upper Limit
        66.6
        value
        52.2
      5. group Id
        OG004
        lower Limit
        36.3
        upper Limit
        69.6
        value
        54.5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      14
    4. group Id
      OG003
      value
      38
    5. group Id
      OG004
      value
      33
    units
    Participants
description
Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
dispersion Type
95% Confidence Interval
groups
  1. description
    SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
    id
    OG000
    title
    Level 5: 10.0 Gy/FX
  2. description
    SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
    id
    OG001
    title
    Level 6: 10.5 Gy/FX
  3. description
    SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
    id
    OG002
    title
    Level 7: 11.0 Gy/FX
  4. description
    SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
    id
    OG003
    title
    Level 8: 11.5 Gy/FX
  5. description
    SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
    id
    OG004
    title
    Level 9: 12.0 Gy/FX
param Type
NUMBER
population Description
All eligible patients who started study treatment
reporting Status
POSTED
time Frame
From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
title
Progression-free Survival
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice