NCT01507428 · OUTCOME

Baseline 18F-fluoromisonidazole (FMISO) Tumor Hypoxic Volume Association With LRPF 2-years Post Registration (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 and 2-years after randomization

What was measured

Tumor Hypoxic Volume (PET-MISO measure) is defined as the number of pixels in the gross tumor volume with a tumor-to-blood pool ratio of \> 1.2, Association With LRPF 2-years Post Registration

Analysis population: Participants enrolled at an institution participating in the FMISO Correlative Study. Note that the company supplying FMISO ceased production early in the study.

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

Source class 1

Values in cm^3 · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Both Arms	29.59	77.14	Not reported	Not reported	Not reported
Arm I (Standard Chemoradiotherapy)	9.65	10.97	Not reported	Not reported	Not reported
Arm II (Experimental Chemoradiotherapy)	42.40	97.70	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Num Sides
TWO_SIDED
group Description
Assess Baseline Tumor Hypoxic volume(HV) Association With LRPF using Hazard ratios along with the associated p-values to compare arms
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.4235
param Type
Hazard Ratio (HR)
param Value
1.002
statistical Method
Regression, Cox

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Description
Assess Baseline Tumor Hypoxic volume(HV) Association With LRPF using Hazard ratios along with the associated p-values to compare arms
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.4235
param Type
Hazard Ratio (HR)
param Value
1.002
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
spread
77.14
value
29.59
group Id
OG001
spread
10.97
value
9.65
group Id
OG002
spread
97.70
value
42.40

denoms

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

description

Tumor Hypoxic Volume (PET-MISO measure) is defined as the number of pixels in the gross tumor volume with a tumor-to-blood pool ratio of \> 1.2, Association With LRPF 2-years Post Registration

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

Participants enrolled at an institution participating in the FMISO Correlative Study. Note that the company supplying FMISO ceased production early in the study.

reporting Status

POSTED

time Frame

Baseline and 2-years after randomization

title

Baseline 18F-fluoromisonidazole (FMISO) Tumor Hypoxic Volume Association With LRPF 2-years Post Registration (ECOG-ACRIN)

type

SECONDARY

unit Of Measure

cm^3

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Preserved source evidence · Not medical advice