Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

LRPF survival is defined as survival without local-regional progression (LRP) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with integration of 8F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), and reviewed centrally based on submitted CT scans. LRP is defined as any of the following: * ≥ 20% increase in any of the target lesions (primary and nodal disease), * ≥ 20% increase in the peak SUV of target lesions, * appearance of one or more new lesions within previously irradiated regions. LRPF-free survival time is defined as time from registration to the date of first local-regional progression, distant recurrence (censored), death without documented LRP (censored), or death. LRPF survival rates are estimated using the Kaplan-Meier method.

Eligible participants

→

primary · POSTED

To determine whether the relative change in SUVpeak (from the baseline to the during-treatment FDG-PET/CT) can predict the LRPF with a 2-year follow up. Relative ΔSUVpeak = (Mid-treatment SUVpeak - baseline SUVpeak)/baseline SUVpeak x 100 LRPF was determined from Randomization up to 2 years

All cases with both baseline and during-treatment FDG-PET/CT scans

→

secondary · POSTED

Local-regional progression (LRP) is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with integration of 8F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), and reviewed centrally based on submitted CT scans. LRP is defined as any of the following: * ≥ 20% increase in any of the target lesions (primary and nodal disease), * ≥ 20% increase in the peak SUV of target lesions, * appearance of one or more new lesions within previously irradiated regions. LRP time is defined as time from randomization to the date of first LRP, distant metastasis without LRP (competing risk), death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Eligible participants

→

secondary · POSTED

Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Eligible participants

→

secondary · POSTED

Progression is defined as the first of the following: local, regional, distant progression, or death due to any cause. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Two-year estimates are provided.

Eligible participants

→

secondary · POSTED

A lung cancer death is defined as cause of death designated as lung cancer or death with any evidence of disease progression at any site without a direct evidence of other cause of death. Time to lung cancer death is defined as time from randomization to the date of lung cancer death, last known follow-up (censored), or death without lung cancer (competing risk). Lung cancer death rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.

Eligible participants

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id: NCT01507428
trial label: Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0000
source section id
NCT01507428-om-0000
source outcome index
0
endpoint
Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG)
endpoint definition
LRPF survival is defined as survival without local-regional progression (LRP) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with integration of 8F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), and reviewed centrally based on submitted CT scans. LRP is defined as any of the following: * ≥ 20% increase in any of the target lesions (primary and nodal disease), * ≥ 20% increase in the peak SUV of target lesions, * appearance of one or more new lesions within previously irradiated regions. LRPF-free survival time is defined as time from registration to the date of first local-regional progression, distant recurrence (censored), death without documented LRP (censored), or death. LRPF survival rates are estimated using the Kaplan-Meier method.
time origin
Randomization to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0001
source section id
NCT01507428-om-0001
source outcome index
1
endpoint
Relative Change in SUVpeak From the Baseline to the During-treatment Fludeoxyglucose F 18 (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) to LRPF With a 2-year Follow up. (ECOG-ACRIN)
endpoint definition
To determine whether the relative change in SUVpeak (from the baseline to the during-treatment FDG-PET/CT) can predict the LRPF with a 2-year follow up. Relative ΔSUVpeak = (Mid-treatment SUVpeak - baseline SUVpeak)/baseline SUVpeak x 100 LRPF was determined from Randomization up to 2 years
time origin
Baseline to during-treatment (approximately between fractions 18-19) Randomization to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All cases with both baseline and during-treatment FDG-PET/CT scans
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0002
source section id
NCT01507428-om-0002
source outcome index
2
endpoint
Percentage of Participants With Local-regional Progression (NRG)
endpoint definition
Local-regional progression (LRP) is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with integration of 8F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), and reviewed centrally based on submitted CT scans. LRP is defined as any of the following: * ≥ 20% increase in any of the target lesions (primary and nodal disease), * ≥ 20% increase in the peak SUV of target lesions, * appearance of one or more new lesions within previously irradiated regions. LRP time is defined as time from randomization to the date of first LRP, distant metastasis without LRP (competing risk), death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
time origin
From randomization to last follow-up: weekly during treatment, then 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months after end of protocol treatment, then annually. Maximum follow-up at time of reporting was 7.3 years. Two-year rates reported here.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0003
source section id
NCT01507428-om-0003
source outcome index
3
endpoint
Percentage of Participants Alive (Overall Survival) (NRG)
endpoint definition
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
time origin
From randomization to last follow-up: weekly during treatment, then 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months after end of protocol treatment, then annually. Maximum follow-up at time of reporting was 7.3 years. Two-year rates reported here.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0004
source section id
NCT01507428-om-0004
source outcome index
4
endpoint
Percentage of Participants Alive Without Progression (Progression-free Survival) (NRG)
endpoint definition
Progression is defined as the first of the following: local, regional, distant progression, or death due to any cause. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Two-year estimates are provided.
time origin
From randomization to last follow-up: weekly during treatment, then 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months after end of protocol treatment, then annually. Maximum follow-up at time of reporting was 7.3 years. Two-year rates reported here.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0005
source section id
NCT01507428-om-0005
source outcome index
5
endpoint
Percentage of Participants With Death Due to Lung Cancer (NRG)
endpoint definition
A lung cancer death is defined as cause of death designated as lung cancer or death with any evidence of disease progression at any site without a direct evidence of other cause of death. Time to lung cancer death is defined as time from randomization to the date of lung cancer death, last known follow-up (censored), or death without lung cancer (competing risk). Lung cancer death rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
time origin
From randomization to last follow-up: weekly during treatment, then 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months after end of protocol treatment, then annually. Maximum follow-up at time of reporting was 7.3 years. Two-year rates reported here.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0000
arm key
OG000
arm label
Standard Radiation Therapy
regimen
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0000
arm key
OG001
arm label
Adaptive Radiation Therapy
regimen
A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.
analyzed count
84
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0001
arm key
OG000
arm label
Standard Radiation Therapy
regimen
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Baseline FDG-PET/CT scan within 4 weeks prior to registration During-RT FDG-PET/CT Scan between fractions 18 and 19
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0001
arm key
OG001
arm label
Adaptive Radiation Therapy
regimen
A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19. Baseline FDG-PET/CT scan within 4 weeks prior to registration During-RT FDG-PET/CT Scan between fractions 18 and 19
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0002
arm key
OG000
arm label
Standard Radiation Therapy
regimen
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0002
arm key
OG001
arm label
Adaptive Radiation Therapy
regimen
A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.
analyzed count
84
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0003
arm key
OG000
arm label
Standard Radiation Therapy
regimen
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0003
arm key
OG001
arm label
Adaptive Radiation Therapy
regimen
A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.
analyzed count
84
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0004
arm key
OG000
arm label
Standard Radiation Therapy
regimen
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0004
arm key
OG001
arm label
Adaptive Radiation Therapy
regimen
A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.
analyzed count
84
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0005
arm key
OG000
arm label
Standard Radiation Therapy
regimen
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
outcome key
om-0005
arm key
OG001
arm label
Adaptive Radiation Therapy
regimen
A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.
analyzed count
84
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01507428-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
harm key
EG000
source section id
NCT01507428-ae
event group key
EG000
event group label
Standard Radiation Therapy
serious affected
16
serious at risk
43
other affected
42
other at risk
43
frequency threshold
5
collection period
From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01507428
harm key
EG001
source section id
NCT01507428-ae
event group key
EG001
event group label
Adaptive Radiation Therapy
serious affected
26
serious at risk
84
other affected
83
other at risk
84
frequency threshold
5
collection period
From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice