NCT01507428 · OUTCOME

FMISO Hypoxic Tumor Volume (HV) @Baseline, 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: cm^3
Interval / dispersion: Standard Deviation
Time frame: Baseline to up to 5 years

What was measured

FMISO Hypoxic tumor volume @baseline, 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 HV defined as the number of pixels in the gross tumor volume with a tumor-to-blood pool ratio of \> 1.2 in cc LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the HV 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	23
Arm I (Standard Chemoradiotherapy)	9
Arm II (Experimental Chemoradiotherapy)	14

Reported measurements

Responder(No Event)

Analysis denominator · Participants

Group	Source count
Both Arms	9
Arm I (Standard Chemoradiotherapy)	3
Arm II (Experimental Chemoradiotherapy)	6

Values in cm^3 · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Both Arms	18.08	31.177	Not reported	Not reported	Not reported
Arm I (Standard Chemoradiotherapy)	12.42	15.385	Not reported	Not reported	Not reported
Arm II (Experimental Chemoradiotherapy)	20.91	37.838	Not reported	Not reported	Not reported

Non-Responder

Analysis denominator · Participants

Group	Source count
Both Arms	14
Arm I (Standard Chemoradiotherapy)	6
Arm II (Experimental Chemoradiotherapy)	8

Values in cm^3 · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Both Arms	36.98	96.549	Not reported	Not reported	Not reported
Arm I (Standard Chemoradiotherapy)	8.27	9.533	Not reported	Not reported	Not reported
Arm II (Experimental Chemoradiotherapy)	58.52	126.530	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
0.2650
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.7985
group Description
Accuracy of HV 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
0.5317
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 HV
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.2222
ci Num Sides
TWO_SIDED
group Description
The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG000
non Inferiority Comment
HV @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal HV threshold
param Value
0.2650
ci Lower Limit
0.0000
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.0000
group Description
Accuracy of HV 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
0.5556
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 HV
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.3333
ci Num Sides
TWO_SIDED
group Description
The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG001
non Inferiority Comment
HV @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal HV threshold
param Value
7.6300
ci Lower Limit
0.2271
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.8979
group Description
Accuracy of HV 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
0.5625
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 HV
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.2083
ci Num Sides
TWO_SIDED
group Description
The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG002
non Inferiority Comment
HV @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal HV threshold
param Value
19.5900

Complete source fields

analyses

ci Lower Limit
0.2650
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.7985
group Description
Accuracy of HV 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
0.5317
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 HV
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.2222
ci Num Sides
TWO_SIDED
group Description
The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG000
non Inferiority Comment
HV @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal HV threshold
param Value
0.2650
ci Lower Limit
0.0000
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.0000
group Description
Accuracy of HV 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
0.5556
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 HV
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.3333
ci Num Sides
TWO_SIDED
group Description
The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG001
non Inferiority Comment
HV @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal HV threshold
param Value
7.6300
ci Lower Limit
0.2271
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.8979
group Description
Accuracy of HV 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
0.5625
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 HV
non Inferiority Type
OTHER
param Type
Youdin index
param Value
0.2083
ci Num Sides
TWO_SIDED
group Description
The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index
group Ids
OG002
non Inferiority Comment
HV @ Max(Youden index)
non Inferiority Type
OTHER
param Type
Optimal HV threshold
param Value
19.5900

classes

categories
measurements
group Id
OG000
spread
31.177
value
18.08
group Id
OG001
spread
15.385
value
12.42
group Id
OG002
spread
37.838
value
20.91
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
3
group Id
OG002
value
6
units
Participants
title
Responder(No Event)
categories
measurements
group Id
OG000
spread
96.549
value
36.98
group Id
OG001
spread
9.533
value
8.27
group Id
OG002
spread
126.530
value
58.52
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
6
group Id
OG002
value
8
units
Participants
title
Non-Responder

denoms

counts
group Id
OG000
value
23
group Id
OG001
value
9
group Id
OG002
value
14
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

FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)

type

SECONDARY

unit Of Measure

cm^3

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Preserved source evidence · Not medical advice