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NCT01507428 · OUTCOME

Percentage of Participants With Grade 3+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events 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

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; See Adverse Events Module for specific adverse event data.

Analysis population: Eligible participants who started study treatment

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 Therapy42
Adaptive Radiation Therapy80

Reported measurements

Esophagitis
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Radiation Therapy7.1Not reported1.519.5Not reported
Adaptive Radiation Therapy3.8Not reported0.810.6Not reported
Pericardial Effusion
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Radiation Therapy0Not reportedNANAInsufficient number of participants with events
Adaptive Radiation Therapy0Not reportedNANAInsufficient number of participants with events
Cardiac adverse events
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Radiation Therapy2.4Not reported0.112.6Not reported
Adaptive Radiation Therapy1.3Not reported0.06.8Not reported

Source statistical analyses

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

  1. group Description
    Esophagitis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4133
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
  2. group Description
    Cardiac adverse events
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.000
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Esophagitis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4133
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
  2. group Description
    Cardiac adverse events
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.000
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        19.5
        value
        7.1
      2. group Id
        OG001
        lower Limit
        0.8
        upper Limit
        10.6
        value
        3.8
    title
    Esophagitis
  2. categories
    1. measurements
      1. comment
        Insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      2. comment
        Insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0
    title
    Pericardial Effusion
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        12.6
        value
        2.4
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        6.8
        value
        1.3
    title
    Cardiac adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      80
    units
    Participants
description
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; See Adverse Events Module for specific adverse event data.
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 who started study treatment
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+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events at Any Time (NRG)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice