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NCT00750269 · OUTCOME

Nodal Progression

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 patients
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to date of death, regional failure 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

Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure 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 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 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 patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Level 5: 10.0 Gy/FX0Not reportedNANAA confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
Level 6: 10.5 Gy/FX0Not reportedNANAA confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
Level 7: 11.0 Gy/FX7.1Not reported0.428.7Not reported
Level 8: 11.5 Gy/FX5.3Not reported0.915.7Not reported
Level 9: 12.0 Gy/FX6.1Not reported117.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      2. comment
        A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      3. group Id
        OG002
        lower Limit
        0.4
        upper Limit
        28.7
        value
        7.1
      4. group Id
        OG003
        lower Limit
        0.9
        upper Limit
        15.7
        value
        5.3
      5. group Id
        OG004
        lower Limit
        1
        upper Limit
        17.9
        value
        6.1
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
Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
dispersion Type
95% Confidence Interval
groups
  1. description
    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 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, regional failure 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
Nodal Progression
type
SECONDARY
unit Of Measure
percentage of patients

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Preserved source evidence · Not medical advice