NCT01507428 · OUTCOME

FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free 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 ΔSUVpeak, as measured from Baseline to the During-treatment FDG PET/CT, will be assessed in its ability to predict Local-Regional Progression-Free (LRPF) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified ΔSUVpeak defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) LRPF defined as as NO progressive lung cancer within 1 cm from the planning target volume.or Progressive disease in any of the 14 nodal stations beyond 1cm 2 Years from regitration (Responders) OT defined as the ΔSUVpeak 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	17
Arm I (Standard Chemoradiotherapy)	7
Arm II (Experimental Chemoradiotherapy)	10

Values in percent change · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Both Arms	-46.89	26.280	Not reported	Not reported	Not reported
Arm I (Standard Chemoradiotherapy)	-45.48	33.035	Not reported	Not reported	Not reported
Arm II (Experimental Chemoradiotherapy)	-47.87	22.308	Not reported	Not reported	Not reported

Non-Responder

Analysis denominator · Participants

Group	Source count
Both Arms	90
Arm I (Standard Chemoradiotherapy)	29
Arm II (Experimental Chemoradiotherapy)	61

Values in percent change · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Both Arms	-38.47	40.398	Not reported	Not reported	Not reported
Arm I (Standard Chemoradiotherapy)	-36.44	31.496	Not reported	Not reported	Not reported
Arm II (Experimental Chemoradiotherapy)	-39.44	44.215	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
0.3959
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.7205
group Description
Accuracy of ΔSUVpeak to Predict LRPF at year 2 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
0.5582
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 ΔSUVpeak
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.2196
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG000
non Inferiority Comment
ΔSUVpeak @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVpeak threshold
param Value
-66.4450
ci Lower Limit
0.2592
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.8738
group Description
Accuracy of ΔSUVpeak to Predict LRPF at year 2 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
0.5665
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 ΔSUVpeak
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.3596
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG001
non Inferiority Comment
ΔSUVpeak @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVpeak threshold
param Value
-65.7005
ci Lower Limit
0.3554
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.7397
group Description
Accuracy of ΔSUVpeak to Predict LRPF at year 2 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
0.5475
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 ΔSUVpeak
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.1787
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG002
non Inferiority Comment
ΔSUVpeak @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVpeak threshold
param Value
-28.0899

Complete source fields

analyses

ci Lower Limit
0.3959
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.7205
group Description
Accuracy of ΔSUVpeak to Predict LRPF at year 2 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
0.5582
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 ΔSUVpeak
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.2196
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG000
non Inferiority Comment
ΔSUVpeak @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVpeak threshold
param Value
-66.4450
ci Lower Limit
0.2592
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.8738
group Description
Accuracy of ΔSUVpeak to Predict LRPF at year 2 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
0.5665
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 ΔSUVpeak
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.3596
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG001
non Inferiority Comment
ΔSUVpeak @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVpeak threshold
param Value
-65.7005
ci Lower Limit
0.3554
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.7397
group Description
Accuracy of ΔSUVpeak to Predict LRPF at year 2 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
0.5475
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 ΔSUVpeak
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.1787
ci Num Sides
TWO_SIDED
group Description
The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG002
non Inferiority Comment
ΔSUVpeak @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal ΔSUVpeak threshold
param Value
-28.0899

classes

categories
measurements
group Id
OG000
spread
26.280
value
-46.89
group Id
OG001
spread
33.035
value
-45.48
group Id
OG002
spread
22.308
value
-47.87
denoms
counts
group Id
OG000
value
17
group Id
OG001
value
7
group Id
OG002
value
10
units
Participants
title
Responder(No Event)
categories
measurements
group Id
OG000
spread
40.398
value
-38.47
group Id
OG001
spread
31.496
value
-36.44
group Id
OG002
spread
44.215
value
-39.44
denoms
counts
group Id
OG000
value
90
group Id
OG001
value
29
group Id
OG002
value
61
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 ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)

type

SECONDARY

unit Of Measure

percent change

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Preserved source evidence · Not medical advice