Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01507428 · OUTCOME

Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (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
Randomization to 2 years

What was measured

LRPF survival is defined as survival without local-regional progression (LRP) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with integration of 8F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), and reviewed centrally based on submitted CT scans. LRP is defined as any of the following: * ≥ 20% increase in any of the target lesions (primary and nodal disease), * ≥ 20% increase in the peak SUV of target lesions, * appearance of one or more new lesions within previously irradiated regions. LRPF-free survival time is defined as time from registration to the date of first local-regional progression, distant recurrence (censored), death without documented LRP (censored), or death. LRPF survival rates are estimated using the Kaplan-Meier method.

Analysis population: Eligible participants

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 Therapy43
Adaptive Radiation Therapy84

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Radiation Therapy59.5Not reported37.975.7Not reported
Adaptive Radiation Therapy54.6Not reported39.967.0Not reported

Source statistical analyses

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

  1. group Description
    Assuming a two-year LRPF rate of 50% in the Standard Radiation Therapy (RT) arm and using a 2:1 randomization in favor of the Adaptive RT arm, 117 eligible patients (78 in the Adaptive RT arm and 39 in the Standard RT arm) provide 85% power to detect a 20% absolute increase in the 2-year LRPF rate at a significance level of 0.15 using a one-sided Z test for 2 proportions.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6585
    statistical Method
    Z-test
Complete source fields
analyses
  1. group Description
    Assuming a two-year LRPF rate of 50% in the Standard Radiation Therapy (RT) arm and using a 2:1 randomization in favor of the Adaptive RT arm, 117 eligible patients (78 in the Adaptive RT arm and 39 in the Standard RT arm) provide 85% power to detect a 20% absolute increase in the 2-year LRPF rate at a significance level of 0.15 using a one-sided Z test for 2 proportions.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6585
    statistical Method
    Z-test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.9
        upper Limit
        75.7
        value
        59.5
      2. group Id
        OG001
        lower Limit
        39.9
        upper Limit
        67.0
        value
        54.6
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      84
    units
    Participants
description
LRPF survival is defined as survival without local-regional progression (LRP) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with integration of 8F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), and reviewed centrally based on submitted CT scans. LRP is defined as any of the following: * ≥ 20% increase in any of the target lesions (primary and nodal disease), * ≥ 20% increase in the peak SUV of target lesions, * appearance of one or more new lesions within previously irradiated regions. LRPF-free survival time is defined as time from registration to the date of first local-regional progression, distant recurrence (censored), death without documented LRP (censored), or death. LRPF survival rates are estimated using the Kaplan-Meier method.
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
reporting Status
POSTED
time Frame
Randomization to 2 years
title
Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice