NCT01507428 · OUTCOME
Relative Change in SUV Peak From the Baseline to the During-treatment FDG PET/CT Prediction of the Differential Benefit of the Adaptive Therapy (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 after randomization
What was measured
Relative change in SUVpeak defined as ΔSUVpeak = (during-treatment SUVpeak - baseline SUVpeak)/baseline SUVpeak x 100%), Outcomes evaluated at 5 years. Overall Survival (OS): True if Alive 5 years from registration Progression Free Survival (PFS): True if Alive and no Progression 5 years from registration Lung Cancer Cause-specific Survival (LCCS): True if Alive and no Lung Cancer 5 years from registration
Analysis population: Number analyzed represents the sample population having the specified (Row title) condition For example: of the 107 participants, 38 were alive after 5 years and had a ΔSUVpeak=-34.71
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
Alive (OS) : True
Analysis denominator · Participants
| Group | Source count |
|---|
| Both Arms | 38 |
|---|
| Arm I (Standard Chemoradiotherapy) | 14 |
|---|
| Arm II (Experimental Chemoradiotherapy) | 24 |
|---|
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Both Arms | -34.71 | 53.23 | Not reported | Not reported | Not reported |
|---|
| Arm I (Standard Chemoradiotherapy) | -44.13 | 27.07 | Not reported | Not reported | Not reported |
|---|
| Arm II (Experimental Chemoradiotherapy) | -29.21 | 63.17 | Not reported | Not reported | Not reported |
|---|
Alive (OS) : False
Analysis denominator · Participants
| Group | Source count |
|---|
| Both Arms | 69 |
|---|
| Arm I (Standard Chemoradiotherapy) | 22 |
|---|
| Arm II (Experimental Chemoradiotherapy) | 47 |
|---|
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Both Arms | -42.62 | 27.37 | Not reported | Not reported | Not reported |
|---|
| Arm I (Standard Chemoradiotherapy) | -34.43 | 34.13 | Not reported | Not reported | Not reported |
|---|
| Arm II (Experimental Chemoradiotherapy) | -46.45 | 22.99 | Not reported | Not reported | Not reported |
|---|
Progression Free (PFS) : True
Analysis denominator · Participants
| Group | Source count |
|---|
| Both Arms | 19 |
|---|
| Arm I (Standard Chemoradiotherapy) | 9 |
|---|
| Arm II (Experimental Chemoradiotherapy) | 10 |
|---|
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Both Arms | -44.36 | 26.77 | Not reported | Not reported | Not reported |
|---|
| Arm I (Standard Chemoradiotherapy) | -40.46 | 31.93 | Not reported | Not reported | Not reported |
|---|
| Arm II (Experimental Chemoradiotherapy) | -47.87 | 22.31 | Not reported | Not reported | Not reported |
|---|
Progression Free (PFS) : False
Analysis denominator · Participants
| Group | Source count |
|---|
| Both Arms | 88 |
|---|
| Arm I (Standard Chemoradiotherapy) | 27 |
|---|
| Arm II (Experimental Chemoradiotherapy) | 61 |
|---|
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Both Arms | -38.82 | 40.68 | Not reported | Not reported | Not reported |
|---|
| Arm I (Standard Chemoradiotherapy) | -37.44 | 31.97 | Not reported | Not reported | Not reported |
|---|
| Arm II (Experimental Chemoradiotherapy) | -39.44 | 44.21 | Not reported | Not reported | Not reported |
|---|
Lung Cancer Cause-specific Survival (LCCS) True
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 | -39.15 | 49.02 | Not reported | Not reported | Not reported |
|---|
| Arm I (Standard Chemoradiotherapy) | -42.35 | 25.90 | Not reported | Not reported | Not reported |
|---|
| Arm II (Experimental Chemoradiotherapy) | -37.55 | 57.54 | Not reported | Not reported | Not reported |
|---|
Lung Cancer Cause-specific Survival (LCCS): False
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 | -40.34 | 27.65 | Not reported | Not reported | Not reported |
|---|
| Arm I (Standard Chemoradiotherapy) | -34.88 | 35.71 | Not reported | Not reported | Not reported |
|---|
| Arm II (Experimental Chemoradiotherapy) | -43.15 | 22.49 | 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
- 0.041
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.334
- group Description
- The differential benefit in prediction of Overall Survival occurs at the smallest measure such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.235
- ci Num Sides
- TWO_SIDED
- group Description
- Estimate Min Hazard (cutoff) for ΔSUVpeak between arms. The differential benefit in prediction of Overall Survival occurs at the smallest measure (of ΔSUVpeak) such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Comment
- min ΔSUVpeak such that differential benefit in prediction of Overall Survival occurs at the smallest measure where Arm I becomes superior to Arm II
- non Inferiority Type
- OTHER
- param Type
- ΔSUVpeak representing Min Hazard
- param Value
- -54.30
- ci Lower Limit
- 0.524
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.737
- group Description
- The differential benefit in prediction of PFS occurs at the smallest measure such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.954
- ci Num Sides
- TWO_SIDED
- group Description
- Estimate Min Hazard (cutoff) for ΔSUVpeak between arms. The differential benefit in prediction of PFS occurs at the smallest measure (of ΔSUVpeak) such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Comment
- min ΔSUVpeak such that differential benefit in prediction ofPFS occurs at the smallest measure where Arm I becomes superior to Arm II
- non Inferiority Type
- OTHER
- param Type
- ΔSUVpeak representing Min Hazard
- param Value
- -13.20
- ci Lower Limit
- 0.304
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.482
- group Description
- The differential benefit in prediction of LCCS occurs at the smallest measure such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff occurs when HR=1
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.672
- ci Num Sides
- TWO_SIDED
- group Description
- Estimate Min Hazard (cutoff) for ΔSUVpeak between arms. The differential benefit in prediction of LCCS occurs at the smallest measure (of ΔSUVpeak) such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Comment
- min ΔSUVpeak such that differential benefit in prediction of LCCS occurs at the smallest measure where Arm I becomes superior to Arm II
- non Inferiority Type
- OTHER
- param Type
- ΔSUVpeak representing Min Hazard
- param Value
- -5.547
Complete source fields
- analyses
- ci Lower Limit
- 0.041
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.334
- group Description
- The differential benefit in prediction of Overall Survival occurs at the smallest measure such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.235
- ci Num Sides
- TWO_SIDED
- group Description
- Estimate Min Hazard (cutoff) for ΔSUVpeak between arms. The differential benefit in prediction of Overall Survival occurs at the smallest measure (of ΔSUVpeak) such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Comment
- min ΔSUVpeak such that differential benefit in prediction of Overall Survival occurs at the smallest measure where Arm I becomes superior to Arm II
- non Inferiority Type
- OTHER
- param Type
- ΔSUVpeak representing Min Hazard
- param Value
- -54.30
- ci Lower Limit
- 0.524
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.737
- group Description
- The differential benefit in prediction of PFS occurs at the smallest measure such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.954
- ci Num Sides
- TWO_SIDED
- group Description
- Estimate Min Hazard (cutoff) for ΔSUVpeak between arms. The differential benefit in prediction of PFS occurs at the smallest measure (of ΔSUVpeak) such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Comment
- min ΔSUVpeak such that differential benefit in prediction ofPFS occurs at the smallest measure where Arm I becomes superior to Arm II
- non Inferiority Type
- OTHER
- param Type
- ΔSUVpeak representing Min Hazard
- param Value
- -13.20
- ci Lower Limit
- 0.304
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.482
- group Description
- The differential benefit in prediction of LCCS occurs at the smallest measure such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff occurs when HR=1
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.672
- ci Num Sides
- TWO_SIDED
- group Description
- Estimate Min Hazard (cutoff) for ΔSUVpeak between arms. The differential benefit in prediction of LCCS occurs at the smallest measure (of ΔSUVpeak) such that Arm I (standard chemoradiotherapy) becomes superior to Arm II(experimental chemoradiotherapy)
Using the Cox:
HR\_BvsA (SUV) = exp(β2 +β3 \*SUV) and B is better than A when β2 +β3 \*SUV=0 the cutoff is when HR=1
- non Inferiority Comment
- min ΔSUVpeak such that differential benefit in prediction of LCCS occurs at the smallest measure where Arm I becomes superior to Arm II
- non Inferiority Type
- OTHER
- param Type
- ΔSUVpeak representing Min Hazard
- param Value
- -5.547
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 53.23
- value
- -34.71
- group Id
- OG001
- spread
- 27.07
- value
- -44.13
- group Id
- OG002
- spread
- 63.17
- value
- -29.21
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Alive (OS) : True
- categories
- measurements
- group Id
- OG000
- spread
- 27.37
- value
- -42.62
- group Id
- OG001
- spread
- 34.13
- value
- -34.43
- group Id
- OG002
- spread
- 22.99
- value
- -46.45
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 47
- units
- Participants
- title
- Alive (OS) : False
- categories
- measurements
- group Id
- OG000
- spread
- 26.77
- value
- -44.36
- group Id
- OG001
- spread
- 31.93
- value
- -40.46
- group Id
- OG002
- spread
- 22.31
- value
- -47.87
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 10
- units
- Participants
- title
- Progression Free (PFS) : True
- categories
- measurements
- group Id
- OG000
- spread
- 40.68
- value
- -38.82
- group Id
- OG001
- spread
- 31.97
- value
- -37.44
- group Id
- OG002
- spread
- 44.21
- value
- -39.44
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 61
- units
- Participants
- title
- Progression Free (PFS) : False
- categories
- measurements
- group Id
- OG000
- spread
- 49.02
- value
- -39.15
- group Id
- OG001
- spread
- 25.90
- value
- -42.35
- group Id
- OG002
- spread
- 57.54
- value
- -37.55
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 32
- units
- Participants
- title
- Lung Cancer Cause-specific Survival (LCCS) True
- categories
- measurements
- group Id
- OG000
- spread
- 27.65
- value
- -40.34
- group Id
- OG001
- spread
- 35.71
- value
- -34.88
- group Id
- OG002
- spread
- 22.49
- value
- -43.15
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 39
- units
- Participants
- title
- Lung Cancer Cause-specific Survival (LCCS): False
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 36
- group Id
- OG002
- value
- 71
- units
- Participants
- description
- Relative change in SUVpeak defined as ΔSUVpeak = (during-treatment SUVpeak - baseline SUVpeak)/baseline SUVpeak x 100%), Outcomes evaluated at 5 years. Overall Survival (OS): True if Alive 5 years from registration Progression Free Survival (PFS): True if Alive and no Progression 5 years from registration Lung Cancer Cause-specific Survival (LCCS): True if Alive and no Lung Cancer 5 years from 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
- Number analyzed represents the sample population having the specified (Row title) condition For example: of the 107 participants, 38 were alive after 5 years and had a ΔSUVpeak=-34.71
- reporting Status
- POSTED
- time Frame
- Baseline to up to 5 years after randomization
- title
- Relative Change in SUV Peak From the Baseline to the During-treatment FDG PET/CT Prediction of the Differential Benefit of the Adaptive Therapy (ECOG-ACRIN)
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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