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NCT00750269 · OUTCOME

Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0

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 start of treatment to end of 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

Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.

Analysis population: All eligible patients who started study treatment who were observed more than 1 year after start of SBRT

Groups in this outcome

Level 5: 10.0 Gy/FX

SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

Level 6: 10.5 Gy/FX

SBRT 52.5 Gy 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 55.0 Gy 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/FX5
Level 7: 11.0 Gy/FX12
Level 8: 11.5 Gy/FX32
Level 9: 12.0 Gy/FX31

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Level 5: 10.0 Gy/FX0Not reported00Not reported
Level 6: 10.5 Gy/FX0Not reported00Not reported
Level 7: 11.0 Gy/FX16.7Not reported2.148.4Not reported
Level 8: 11.5 Gy/FX6.3Not reported0.820.8Not reported
Level 9: 12.0 Gy/FX16.1Not reported5.533.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        2.1
        upper Limit
        48.4
        value
        16.7
      4. group Id
        OG003
        lower Limit
        0.8
        upper Limit
        20.8
        value
        6.3
      5. group Id
        OG004
        lower Limit
        5.5
        upper Limit
        33.7
        value
        16.1
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      32
    5. group Id
      OG004
      value
      31
    units
    Participants
description
Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.
dispersion Type
95% Confidence Interval
groups
  1. description
    SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
    id
    OG000
    title
    Level 5: 10.0 Gy/FX
  2. description
    SBRT 52.5 Gy 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 55.0 Gy 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 who were observed more than 1 year after start of SBRT
reporting Status
POSTED
time Frame
From start of treatment to end of 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
Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice