NCT01507428 · OUTCOME

FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)

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: MEAN
Unit: percent change
Interval / dispersion: Standard Deviation
Time frame: Baseline to up to 5 years

What was measured

FDG ΔSUVmax, as measured from Baseline to the During-treatment FDG PET/CT, will be assessed in its ability to predict Lung Cancer Cause-specific Survival (LCCS) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified ΔSUVmax defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the ΔSUVmax value corresponding to the maximum Youden index

Analysis population: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed

Groups in this outcome

Both Arms

Patients undergo chemoradiotherapy as defined for the arm of the study to which they were randomized. 18F-Fluoromisonidazole: Undergo FMISO PET/CT prior to therapy for patients enrolling at institutions participating in the FMISO correlative study

Arm I (Standard Chemoradiotherapy)

Patients undergo standard radiotherapy QD 5 days a week for 30 fractions. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FMISO-PET imaging at baseline 18F-Fluoromisonidazole: Undergo FMISO PET/CT prior to therapy for patients enrolling at institutions participating in the FMISO correlative study Carboplatin: Given IV External Beam Radiation Therapy: Undergo radiotherapy

Arm II (Experimental Chemoradiotherapy)

Patients undergo an individualized dose of image-guided radiotherapy QD 5 days a week for 30 fractions and undergo 18 F FDG-PET/CT between fractions 18 and 19. Based on the scan results, patients undergo individualized adaptive radiotherapy for the final 9 fractions. Patients also receive paclitaxel and carboplatin as in Arm I. 18F-Fluoromisonidazole: Participants enrolled at institutions participating in the FMISO correlative study undergo FMISO-PET prior to treatment Carboplatin: Given IV Computed Tomography: Undergo FDG PET/CT Computed Tomography: Undergo FMISO PET/CT (Correlative studies) Fludeoxyglucose F-18: Undergo FDG PET/CT Image-Guided Adaptive Radiation Therapy: Undergo individualized adaptive radiotherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Positron Emission Tomography: Undergo FDG PET/CT Positron Emission Tomography: Undergo FMISO PET/CT (Correlative studies)

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

Analysis denominator · Participants

Group	Source count
Both Arms	107
Arm I (Standard Chemoradiotherapy)	36
Arm II (Experimental Chemoradiotherapy)	71

Reported measurements

Responder(No Event)

Analysis denominator · Participants

Group	Source count
Both Arms	48
Arm I (Standard Chemoradiotherapy)	16
Arm II (Experimental Chemoradiotherapy)	32

Values in percent change · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Both Arms	-41.94	27.877	Not reported	Not reported	Not reported
Arm I (Standard Chemoradiotherapy)	-39.55	25.183	Not reported	Not reported	Not reported
Arm II (Experimental Chemoradiotherapy)	-43.14	29.443	Not reported	Not reported	Not reported

Non-Responder

Analysis denominator · Participants

Group	Source count
Both Arms	59
Arm I (Standard Chemoradiotherapy)	20
Arm II (Experimental Chemoradiotherapy)	39

Values in percent change · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Both Arms	-38.87	30.613	Not reported	Not reported	Not reported
Arm I (Standard Chemoradiotherapy)	-32.87	39.834	Not reported	Not reported	Not reported
Arm II (Experimental Chemoradiotherapy)	-41.95	24.666	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.4107
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.6337
group Description
Accuracy of ΔSUVmax to Predict LCCS at year 5 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index
group Ids
OG000
non Inferiority Comment
The AUC/C-statistic is a measure of discrimination between responders and non-responders
non Inferiority Type
OTHER
param Type
AUC
param Value
0.5222
ci Num Sides
TWO_SIDED
group Description
Maximum Youden index
group Ids
OG000
non Inferiority Comment
Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation. Youden index (max( sensitivity + specificity-1)) over all ΔSUVmax
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.0943
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG000
non Inferiority Comment
ΔSUVmax @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVmax threshold
param Value
-36.1248
ci Lower Limit
0.3016
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.6984
group Description
Accuracy of ΔSUVmax to Predict LCCS at year 5 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index
group Ids
OG001
non Inferiority Comment
The AUC/C-statistic is a measure of discrimination between responders and non-responders
non Inferiority Type
OTHER
param Type
AUC
param Value
0.5000
ci Num Sides
TWO_SIDED
group Description
Maximum Youden index
group Ids
OG001
non Inferiority Comment
Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation. Youden index (max( sensitivity + specificity-1)) over all ΔSUVmax
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.1500
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG001
non Inferiority Comment
ΔSUVmax @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVmax threshold
param Value
-67.5365
ci Lower Limit
0.3913
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.6664
group Description
Accuracy of ΔSUVmax to Predict LCCS at year 5 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index
group Ids
OG002
non Inferiority Comment
The AUC/C-statistic is a measure of discrimination between responders and non-responders
non Inferiority Type
OTHER
param Type
AUC
param Value
0.5288
ci Num Sides
TWO_SIDED
group Description
Maximum Youden index
group Ids
OG002
non Inferiority Comment
Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation. Youden index (max( sensitivity + specificity-1)) over all ΔSUVmax
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.0986
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG002
non Inferiority Comment
ΔSUVmax @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVmax threshold
param Value
-58.3487

Complete source fields

analyses

ci Lower Limit
0.4107
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.6337
group Description
Accuracy of ΔSUVmax to Predict LCCS at year 5 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index
group Ids
OG000
non Inferiority Comment
The AUC/C-statistic is a measure of discrimination between responders and non-responders
non Inferiority Type
OTHER
param Type
AUC
param Value
0.5222
ci Num Sides
TWO_SIDED
group Description
Maximum Youden index
group Ids
OG000
non Inferiority Comment
Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation. Youden index (max( sensitivity + specificity-1)) over all ΔSUVmax
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.0943
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG000
non Inferiority Comment
ΔSUVmax @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVmax threshold
param Value
-36.1248
ci Lower Limit
0.3016
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.6984
group Description
Accuracy of ΔSUVmax to Predict LCCS at year 5 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index
group Ids
OG001
non Inferiority Comment
The AUC/C-statistic is a measure of discrimination between responders and non-responders
non Inferiority Type
OTHER
param Type
AUC
param Value
0.5000
ci Num Sides
TWO_SIDED
group Description
Maximum Youden index
group Ids
OG001
non Inferiority Comment
Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation. Youden index (max( sensitivity + specificity-1)) over all ΔSUVmax
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.1500
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG001
non Inferiority Comment
ΔSUVmax @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVmax threshold
param Value
-67.5365
ci Lower Limit
0.3913
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.6664
group Description
Accuracy of ΔSUVmax to Predict LCCS at year 5 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index
group Ids
OG002
non Inferiority Comment
The AUC/C-statistic is a measure of discrimination between responders and non-responders
non Inferiority Type
OTHER
param Type
AUC
param Value
0.5288
ci Num Sides
TWO_SIDED
group Description
Maximum Youden index
group Ids
OG002
non Inferiority Comment
Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation. Youden index (max( sensitivity + specificity-1)) over all ΔSUVmax
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.0986
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG002
non Inferiority Comment
ΔSUVmax @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVmax threshold
param Value
-58.3487

classes

categories
measurements
group Id
OG000
spread
27.877
value
-41.94
group Id
OG001
spread
25.183
value
-39.55
group Id
OG002
spread
29.443
value
-43.14
denoms
counts
group Id
OG000
value
48
group Id
OG001
value
16
group Id
OG002
value
32
units
Participants
title
Responder(No Event)
categories
measurements
group Id
OG000
spread
30.613
value
-38.87
group Id
OG001
spread
39.834
value
-32.87
group Id
OG002
spread
24.666
value
-41.95
denoms
counts
group Id
OG000
value
59
group Id
OG001
value
20
group Id
OG002
value
39
units
Participants
title
Non-Responder

denoms

counts
group Id
OG000
value
107
group Id
OG001
value
36
group Id
OG002
value
71
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Patients undergo chemoradiotherapy as defined for the arm of the study to which they were randomized. 18F-Fluoromisonidazole: Undergo FMISO PET/CT prior to therapy for patients enrolling at institutions participating in the FMISO correlative study
id
OG000
title
Both Arms
description
Patients undergo standard radiotherapy QD 5 days a week for 30 fractions. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FMISO-PET imaging at baseline 18F-Fluoromisonidazole: Undergo FMISO PET/CT prior to therapy for patients enrolling at institutions participating in the FMISO correlative study Carboplatin: Given IV External Beam Radiation Therapy: Undergo radiotherapy
id
OG001
title
Arm I (Standard Chemoradiotherapy)
description
Patients undergo an individualized dose of image-guided radiotherapy QD 5 days a week for 30 fractions and undergo 18 F FDG-PET/CT between fractions 18 and 19. Based on the scan results, patients undergo individualized adaptive radiotherapy for the final 9 fractions. Patients also receive paclitaxel and carboplatin as in Arm I. 18F-Fluoromisonidazole: Participants enrolled at institutions participating in the FMISO correlative study undergo FMISO-PET prior to treatment Carboplatin: Given IV Computed Tomography: Undergo FDG PET/CT Computed Tomography: Undergo FMISO PET/CT (Correlative studies) Fludeoxyglucose F-18: Undergo FDG PET/CT Image-Guided Adaptive Radiation Therapy: Undergo individualized adaptive radiotherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Positron Emission Tomography: Undergo FDG PET/CT Positron Emission Tomography: Undergo FMISO PET/CT (Correlative studies)
id
OG002
title
Arm II (Experimental Chemoradiotherapy)

param Type

MEAN

population Description

Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed

reporting Status

POSTED

time Frame

Baseline to up to 5 years

title

FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)

type

SECONDARY

unit Of Measure

percent change

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Preserved source evidence · Not medical advice