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NCT01507428 · OUTCOME

Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG)

Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer · Source last updated 2026-04-21

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 last follow-up: weekly during treatment, then 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months after end of protocol treatment, then annually. Maximum follow-up at time of reporting was 7.3 years.

What was measured

RILT is defined as clinical radiation pneumonitis and clinical fibrosis. Grading is defined in the protocol as follows (grade 3 and higher): * Clinical pneumonitis: * Grade 3: Severe cough, unresponsive to narcotic antitussive agent and /or dyspnea at rest, with radiographic evidence of acute pneumonitis, and requiring oxygen (intermittent or continuous) for treatment; * Grade 4: Radiation pneumonitis causes respiratory insufficiency, requiring assisted ventilation; * Grade 5: Radiation pneumonitis directly contributes to the cause of the death; * Clinical fibrosis: * Grade 3: Radiographic evidence of radiation fibrosis causing dyspnea at rest, interfering with activities of daily living, and home oxygen indicated; * Grade 4: Radiation fibrosis causes respiratory insufficiency, requiring assisted ventilation; * Grade 5: Radiation fibrosis directly contributes to the cause of the death.

Analysis population: Eligible participants with RILT data.

Groups in this outcome

Standard Radiation Therapy

60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.

Adaptive Radiation Therapy

A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Standard Radiation Therapy38
Adaptive Radiation Therapy72

Reported measurements

Pneumonitis
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Radiation Therapy5.3Not reported0.617.8Not reported
Adaptive Radiation Therapy6.9Not reported2.315.5Not reported
Fibrosis
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Radiation Therapy5.3Not reported0.617.8Not reported
Adaptive Radiation Therapy1.4Not reported0.07.5Not reported

Source statistical analyses

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

  1. group Description
    Pneumonitis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.0000
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
  2. group Description
    Fibrosis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2736
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Pneumonitis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.0000
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
  2. group Description
    Fibrosis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2736
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        17.8
        value
        5.3
      2. group Id
        OG001
        lower Limit
        2.3
        upper Limit
        15.5
        value
        6.9
    title
    Pneumonitis
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        17.8
        value
        5.3
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        7.5
        value
        1.4
    title
    Fibrosis
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      72
    units
    Participants
description
RILT is defined as clinical radiation pneumonitis and clinical fibrosis. Grading is defined in the protocol as follows (grade 3 and higher): * Clinical pneumonitis: * Grade 3: Severe cough, unresponsive to narcotic antitussive agent and /or dyspnea at rest, with radiographic evidence of acute pneumonitis, and requiring oxygen (intermittent or continuous) for treatment; * Grade 4: Radiation pneumonitis causes respiratory insufficiency, requiring assisted ventilation; * Grade 5: Radiation pneumonitis directly contributes to the cause of the death; * Clinical fibrosis: * Grade 3: Radiographic evidence of radiation fibrosis causing dyspnea at rest, interfering with activities of daily living, and home oxygen indicated; * Grade 4: Radiation fibrosis causes respiratory insufficiency, requiring assisted ventilation; * Grade 5: Radiation fibrosis directly contributes to the cause of the death.
dispersion Type
95% Confidence Interval
groups
  1. description
    60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
    id
    OG000
    title
    Standard Radiation Therapy
  2. description
    A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.
    id
    OG001
    title
    Adaptive Radiation Therapy
param Type
NUMBER
population Description
Eligible participants with RILT data.
reporting Status
POSTED
time Frame
From randomization to last follow-up: weekly during treatment, then 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months after end of protocol treatment, then annually. Maximum follow-up at time of reporting was 7.3 years.
title
Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice