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NCT01507428 · OUTCOME

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

What was measured

FMISO Hypoxic tumor volume (HV) @baseline, 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 HV defined as the number of pixels in the grLRPFs tumor volume with a tumor-to-blood pool ratio of \> 1.2 in cc 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 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

GroupSource count
Both Arms23
Arm I (Standard Chemoradiotherapy)9
Arm II (Experimental Chemoradiotherapy)14

Reported measurements

Responder(No Event)

Analysis denominator · Participants

GroupSource count
Both Arms5
Arm I (Standard Chemoradiotherapy)2
Arm II (Experimental Chemoradiotherapy)3
Values in cm^3 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Both Arms10.8713.104Not reportedNot reportedNot reported
Arm I (Standard Chemoradiotherapy)14.8220.952Not reportedNot reportedNot reported
Arm II (Experimental Chemoradiotherapy)8.249.901Not reportedNot reportedNot reported
Non-Responder

Analysis denominator · Participants

GroupSource count
Both Arms18
Arm I (Standard Chemoradiotherapy)7
Arm II (Experimental Chemoradiotherapy)11
Values in cm^3 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Both Arms34.7986.769Not reportedNot reportedNot reported
Arm I (Standard Chemoradiotherapy)8.188.706Not reportedNot reportedNot reported
Arm II (Experimental Chemoradiotherapy)51.72109.282Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.2196
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.8915
    group Description
    Accuracy of HV 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
    1. 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
    0.5556
  2. ci Num Sides
    TWO_SIDED
    group Description
    Maximum Youden index
    group Ids
    1. 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
    0.2333
  3. 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
    1. OG000
    non Inferiority Comment
    HV @ Max(Youden index)
    non Inferiority Type
    OTHER
    param Type
    Optimal HV threshold
    param Value
    2.7500
  4. 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 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
    1. 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
  5. ci Num Sides
    TWO_SIDED
    group Description
    Maximum Youden index
    group Ids
    1. 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
    0.5000
  6. 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
    1. OG001
    non Inferiority Comment
    HV @ Max(Youden index)
    non Inferiority Type
    OTHER
    param Type
    Optimal HV threshold
    param Value
    26.8500
  7. ci Lower Limit
    0.1842
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.9067
    group Description
    Accuracy of HV 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
    1. 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
    0.5455
  8. ci Num Sides
    TWO_SIDED
    group Description
    Maximum Youden index
    group Ids
    1. 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
    0.3636
  9. 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
    1. OG002
    non Inferiority Comment
    HV @ Max(Youden index)
    non Inferiority Type
    OTHER
    param Type
    Optimal HV threshold
    param Value
    22.9100
Complete source fields
analyses
  1. ci Lower Limit
    0.2196
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.8915
    group Description
    Accuracy of HV 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
    1. 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
    0.5556
  2. ci Num Sides
    TWO_SIDED
    group Description
    Maximum Youden index
    group Ids
    1. 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
    0.2333
  3. 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
    1. OG000
    non Inferiority Comment
    HV @ Max(Youden index)
    non Inferiority Type
    OTHER
    param Type
    Optimal HV threshold
    param Value
    2.7500
  4. 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 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
    1. 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
  5. ci Num Sides
    TWO_SIDED
    group Description
    Maximum Youden index
    group Ids
    1. 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
    0.5000
  6. 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
    1. OG001
    non Inferiority Comment
    HV @ Max(Youden index)
    non Inferiority Type
    OTHER
    param Type
    Optimal HV threshold
    param Value
    26.8500
  7. ci Lower Limit
    0.1842
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.9067
    group Description
    Accuracy of HV 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
    1. 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
    0.5455
  8. ci Num Sides
    TWO_SIDED
    group Description
    Maximum Youden index
    group Ids
    1. 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
    0.3636
  9. 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
    1. OG002
    non Inferiority Comment
    HV @ Max(Youden index)
    non Inferiority Type
    OTHER
    param Type
    Optimal HV threshold
    param Value
    22.9100
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.104
        value
        10.87
      2. group Id
        OG001
        spread
        20.952
        value
        14.82
      3. group Id
        OG002
        spread
        9.901
        value
        8.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Responder(No Event)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        86.769
        value
        34.79
      2. group Id
        OG001
        spread
        8.706
        value
        8.18
      3. group Id
        OG002
        spread
        109.282
        value
        51.72
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Non-Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      14
    units
    Participants
description
FMISO Hypoxic tumor volume (HV) @baseline, 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 HV defined as the number of pixels in the grLRPFs tumor volume with a tumor-to-blood pool ratio of \> 1.2 in cc 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 HV value corresponding to the maximum Youden index
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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)
  3. 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 @Baseline, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
type
SECONDARY
unit Of Measure
cm^3

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Preserved source evidence · Not medical advice