Trial Outcomes & Findings for Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer (NCT NCT01507428)
NCT ID: NCT01507428
Last Updated: 2026-04-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
Randomization to 2 years
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Standard Radiation Therapy
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
90
|
|
Overall Study
Eligible
|
43
|
84
|
|
Overall Study
Eligible and Started Study Treatment
|
42
|
80
|
|
Overall Study
Eligible With Radiation-induced Lung Toxicity
|
38
|
72
|
|
Overall Study
COMPLETED
|
43
|
84
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Standard Radiation Therapy
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
6
|
Baseline Characteristics
Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Standard Radiation Therapy
n=43 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 Participants
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.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=13 Participants
|
65 years
n=13 Participants
|
64 years
n=26 Participants
|
|
Age, Customized
≤ 49 years
|
2 Participants
n=13 Participants
|
6 Participants
n=13 Participants
|
8 Participants
n=26 Participants
|
|
Age, Customized
50 - 59 years
|
8 Participants
n=13 Participants
|
20 Participants
n=13 Participants
|
28 Participants
n=26 Participants
|
|
Age, Customized
60 - 69 years
|
23 Participants
n=13 Participants
|
34 Participants
n=13 Participants
|
57 Participants
n=26 Participants
|
|
Age, Customized
≥ 70 years
|
10 Participants
n=13 Participants
|
24 Participants
n=13 Participants
|
34 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=13 Participants
|
48 Participants
n=13 Participants
|
66 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=13 Participants
|
36 Participants
n=13 Participants
|
61 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=13 Participants
|
70 Participants
n=13 Participants
|
112 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=13 Participants
|
12 Participants
n=13 Participants
|
13 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
3 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
15 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=13 Participants
|
59 Participants
n=13 Participants
|
91 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=13 Participants
|
14 Participants
n=13 Participants
|
16 Participants
n=26 Participants
|
|
Zubrod Performance Status
0
|
17 Participants
n=13 Participants
|
37 Participants
n=13 Participants
|
54 Participants
n=26 Participants
|
|
Zubrod Performance Status
1
|
26 Participants
n=13 Participants
|
47 Participants
n=13 Participants
|
73 Participants
n=26 Participants
|
|
Histology
Squamous cell carcinoma
|
15 Participants
n=13 Participants
|
32 Participants
n=13 Participants
|
47 Participants
n=26 Participants
|
|
Histology
Adenocarcinoma
|
24 Participants
n=13 Participants
|
35 Participants
n=13 Participants
|
59 Participants
n=26 Participants
|
|
Histology
Large cell undifferentiated
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
|
Histology
Non-small-cell lung cancer not otherwise specified (NSCLC NOS)
|
2 Participants
n=13 Participants
|
16 Participants
n=13 Participants
|
18 Participants
n=26 Participants
|
|
Histology
Adenosquamous
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Histology
Non-squamous
|
27 Participants
n=13 Participants
|
51 Participants
n=13 Participants
|
78 Participants
n=26 Participants
|
|
Histology
Squamous
|
16 Participants
n=13 Participants
|
33 Participants
n=13 Participants
|
49 Participants
n=26 Participants
|
|
AJCC Stage
IIIA
|
24 Participants
n=13 Participants
|
46 Participants
n=13 Participants
|
70 Participants
n=26 Participants
|
|
AJCC Stage
IIIB
|
19 Participants
n=13 Participants
|
38 Participants
n=13 Participants
|
57 Participants
n=26 Participants
|
|
Primary Tumor size
≤ 5 cm
|
25 Participants
n=13 Participants
|
50 Participants
n=13 Participants
|
75 Participants
n=26 Participants
|
|
Primary Tumor size
> 5 cm
|
18 Participants
n=13 Participants
|
34 Participants
n=13 Participants
|
52 Participants
n=26 Participants
|
|
Smoking history
Never smoked
|
7 Participants
n=13 Participants
|
7 Participants
n=13 Participants
|
14 Participants
n=26 Participants
|
|
Smoking history
Former smoker, ≤ 10 pack years
|
2 Participants
n=13 Participants
|
6 Participants
n=13 Participants
|
8 Participants
n=26 Participants
|
|
Smoking history
Former smoker, > 10 pack years
|
12 Participants
n=13 Participants
|
28 Participants
n=13 Participants
|
40 Participants
n=26 Participants
|
|
Smoking history
Current smoker
|
15 Participants
n=13 Participants
|
32 Participants
n=13 Participants
|
47 Participants
n=26 Participants
|
|
Smoking history
Unknown
|
7 Participants
n=13 Participants
|
11 Participants
n=13 Participants
|
18 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Randomization to 2 yearsPopulation: Eligible participants
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.
Outcome measures
| Measure |
Standard Radiation Therapy
n=43 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG)
|
59.5 percentage of participants
Interval 37.9 to 75.7
|
54.6 percentage of participants
Interval 39.9 to 67.0
|
—
|
PRIMARY outcome
Timeframe: Baseline to during-treatment (approximately between fractions 18-19) Randomization to 2 yearsPopulation: All cases with both baseline and during-treatment FDG-PET/CT scans
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
Outcome measures
| Measure |
Standard Radiation Therapy
n=36 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=71 Participants
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.
|
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)
|
|---|---|---|---|
|
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)
|
-38.2 percent change
Standard Deviation 31.5
|
-40.6 percent change
Standard Deviation 41.8
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Eligible participants
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.
Outcome measures
| Measure |
Standard Radiation Therapy
n=43 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants With Local-regional Progression (NRG)
|
27.5 percentage of participants
Interval 14.6 to 42.1
|
32.5 percentage of participants
Interval 22.4 to 42.9
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Eligible participants
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.
Outcome measures
| Measure |
Standard Radiation Therapy
n=43 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants Alive (Overall Survival) (NRG)
|
64.7 percentage of participants
Interval 47.7 to 77.3
|
56.3 percentage of participants
Interval 44.8 to 66.4
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Eligible participants
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.
Outcome measures
| Measure |
Standard Radiation Therapy
n=43 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants Alive Without Progression (Progression-free Survival) (NRG)
|
27.6 percentage of participants
Interval 14.9 to 41.8
|
33.9 percentage of participants
Interval 23.8 to 44.2
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Eligible participants
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.
Outcome measures
| Measure |
Standard Radiation Therapy
n=43 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants With Death Due to Lung Cancer (NRG)
|
30.3 percentage of participants
Interval 16.8 to 45.1
|
36.2 percentage of participants
Interval 25.8 to 46.7
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Eligible participants with RILT data.
RILT is defined as clinical radiation pneumonitis and clinical fibrosis. Grading is defined in the protocol as follows (grade 3 and higher): * Clinical pneumonitis: * Grade 3: Severe cough, unresponsive to narcotic antitussive agent and /or dyspnea at rest, with radiographic evidence of acute pneumonitis, and requiring oxygen (intermittent or continuous) for treatment; * Grade 4: Radiation pneumonitis causes respiratory insufficiency, requiring assisted ventilation; * Grade 5: Radiation pneumonitis directly contributes to the cause of the death; * Clinical fibrosis: * Grade 3: Radiographic evidence of radiation fibrosis causing dyspnea at rest, interfering with activities of daily living, and home oxygen indicated; * Grade 4: Radiation fibrosis causes respiratory insufficiency, requiring assisted ventilation; * Grade 5: Radiation fibrosis directly contributes to the cause of the death.
Outcome measures
| Measure |
Standard Radiation Therapy
n=38 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=72 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG)
Pneumonitis
|
5.3 percentage of participants
Interval 0.6 to 17.8
|
6.9 percentage of participants
Interval 2.3 to 15.5
|
—
|
|
Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG)
Fibrosis
|
5.3 percentage of participants
Interval 0.6 to 17.8
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Eligible participants who started study treatment
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; See Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Standard Radiation Therapy
n=42 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=80 Participants
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.
|
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)
|
|---|---|---|---|
|
Percentage of Participants With Grade 3+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events at Any Time (NRG)
Esophagitis
|
7.1 percentage of participants
Interval 1.5 to 19.5
|
3.8 percentage of participants
Interval 0.8 to 10.6
|
—
|
|
Percentage of Participants With Grade 3+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events at Any Time (NRG)
Pericardial Effusion
|
0 percentage of participants
Insufficient number of participants with events
|
0 percentage of participants
Insufficient number of participants with events
|
—
|
|
Percentage of Participants With Grade 3+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events at Any Time (NRG)
Cardiac adverse events
|
2.4 percentage of participants
Interval 0.1 to 12.6
|
1.3 percentage of participants
Interval 0.0 to 6.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and 2-years after randomizationPopulation: Participants enrolled at an institution participating in the FMISO Correlative Study. Note that the company supplying FMISO ceased production early in the study.
Baseline PET-MISO measures are normalized to blood uptake (ie., tumor-to-blood pool ratio) : Tumor SUV Mean, Tumor SUV Max, Tumor SUV Peak Association with LRPF 2-years post registration (That is, evaluate baseline FMISO-PET uptake as a prognostic marker of LRPF)
Outcome measures
| Measure |
Standard Radiation Therapy
n=23 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=9 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=14 Participants
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)
|
|---|---|---|---|
|
Baseline 18F-fluoromisonidazole (FMISO) Uptake (Tumor-to-blood Pool Ratio) Measures Association With LRPF 2-years Post Registration (ECOG-ACRIN)
TUMOR SUV(MEAN)
|
1.60 SUV
Standard Deviation 0.33
|
1.48 SUV
Standard Deviation 0.17
|
1.68 SUV
Standard Deviation 0.39
|
|
Baseline 18F-fluoromisonidazole (FMISO) Uptake (Tumor-to-blood Pool Ratio) Measures Association With LRPF 2-years Post Registration (ECOG-ACRIN)
TUMOR SUV(MAX) All
|
2.73 SUV
Standard Deviation 0.81
|
2.50 SUV
Standard Deviation 0.55
|
2.88 SUV
Standard Deviation 1.03
|
|
Baseline 18F-fluoromisonidazole (FMISO) Uptake (Tumor-to-blood Pool Ratio) Measures Association With LRPF 2-years Post Registration (ECOG-ACRIN)
TUMOR SUV(PEAK)
|
2.23 SUV
Standard Deviation 0.71
|
2.05 SUV
Standard Deviation 0.46
|
2.34 SUV
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline and 2-years after randomizationPopulation: Participants enrolled at an institution participating in the FMISO Correlative Study. Note that the company supplying FMISO ceased production early in the study.
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
Outcome measures
| Measure |
Standard Radiation Therapy
n=23 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=9 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=14 Participants
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)
|
|---|---|---|---|
|
Baseline 18F-fluoromisonidazole (FMISO) Tumor Hypoxic Volume Association With LRPF 2-years Post Registration (ECOG-ACRIN)
|
29.59 cm^3
Standard Deviation 77.14
|
9.65 cm^3
Standard Deviation 10.97
|
42.40 cm^3
Standard Deviation 97.70
|
SECONDARY outcome
Timeframe: Baseline to up to 5 years after randomizationPopulation: 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
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
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
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)
Lung Cancer Cause-specific Survival (LCCS) True
|
-39.15 percent change
Standard Deviation 49.02
|
-42.35 percent change
Standard Deviation 25.90
|
-37.55 percent change
Standard Deviation 57.54
|
|
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)
Alive (OS) : True
|
-34.71 percent change
Standard Deviation 53.23
|
-44.13 percent change
Standard Deviation 27.07
|
-29.21 percent change
Standard Deviation 63.17
|
|
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)
Alive (OS) : False
|
-42.62 percent change
Standard Deviation 27.37
|
-34.43 percent change
Standard Deviation 34.13
|
-46.45 percent change
Standard Deviation 22.99
|
|
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)
Progression Free (PFS) : True
|
-44.36 percent change
Standard Deviation 26.77
|
-40.46 percent change
Standard Deviation 31.93
|
-47.87 percent change
Standard Deviation 22.31
|
|
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)
Progression Free (PFS) : False
|
-38.82 percent change
Standard Deviation 40.68
|
-37.44 percent change
Standard Deviation 31.97
|
-39.44 percent change
Standard Deviation 44.21
|
|
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)
Lung Cancer Cause-specific Survival (LCCS): False
|
-40.34 percent change
Standard Deviation 27.65
|
-34.88 percent change
Standard Deviation 35.71
|
-43.15 percent change
Standard Deviation 22.49
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Responders and non-responders are placed in separate rows. Number analyzed represents the denominator for the estimated value sum of rows = Overall Number of Participants Analyzed
FDG SUVmax as measured at baseline PET imaging will be assessed in its ability to predict Overall Survival (OS) at year 5.
Outcome measures
| Measure |
Standard Radiation Therapy
n=114 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=40 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=74 Participants
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)
|
|---|---|---|---|
|
SUVmax at Baseline Prediction of OS and Optimal Threshold (ECOG-ACRIN)
Alive
|
19.85 SUV
Standard Deviation 9.36
|
21.00 SUV
Standard Deviation 7.34
|
19.16 SUV
Standard Deviation 10.47
|
|
SUVmax at Baseline Prediction of OS and Optimal Threshold (ECOG-ACRIN)
Event (death)
|
17.66 SUV
Standard Deviation 8.89
|
14.78 SUV
Standard Deviation 8.14
|
19.12 SUV
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Responders and non-responders are placed in separate rows. Number analyzed represents the denominator for the estimated value sum of rows = Overall Number of Participants Analyzed
FDG ΔSUVmax as measured at baseline PET imaging will be assessed in its ability to predict Overall Survival (OS) at year 5. Relative change in FDG SUVmax defined as ΔSUVmax = (during-treatment SUVmax - baseline SUVmax )/baseline SUVmax x 100%), Outcomes evaluated at 5 years. Overall Survival (OS): True if Alive 5 years from registration.
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔSUVmax, From Baseline to the During-treatment FDG PET/CT, to Predict OS and Optimal Threshold (ECOG-ACRIN)
Alive
|
-38.68 percent change
Standard Deviation 28.57
|
-39.13 percent change
Standard Deviation 27.02
|
-38.42 percent change
Standard Deviation 30.01
|
|
FDG ΔSUVmax, From Baseline to the During-treatment FDG PET/CT, to Predict OS and Optimal Threshold (ECOG-ACRIN)
Event (death)
|
-41.11 percent change
Standard Deviation 29.90
|
-33.75 percent change
Standard Deviation 38.00
|
-44.56 percent change
Standard Deviation 24.98
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: As a predictive marker, relative SUVpeak is reported by survival status in each survival category. For example, Relative ΔSUVpeak is reported separately for the 38 participants who were alive at the 5 year milestone and for the 69 patients who were not.
ΔSUVpeak will be measured as 100\* (SUVpeak Mid-treatment - SUVpeak baseline)/(SUVpeak baseline) All survival measures will be measured in days from registration up to 5 years.
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN)
ΔSUVpeak (Alive)
|
-34.71 percent change
Standard Deviation 53.23
|
-44.13 percent change
Standard Deviation 27.07
|
-29.21 percent change
Standard Deviation 63.71
|
|
ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN)
ΔSUVpeak (Deceased)
|
-42.62 percent change
Standard Deviation 27.37
|
-34.43 percent change
Standard Deviation 34.13
|
-46.45 percent change
Standard Deviation 22.99
|
|
ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN)
ΔSUVpeak (Alive - No progression)
|
-44.36 percent change
Standard Deviation 26.77
|
-40.46 percent change
Standard Deviation 31.93
|
-47.87 percent change
Standard Deviation 22.31
|
|
ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN)
ΔSUVpeak (Progression/Deceased)
|
-38.82 percent change
Standard Deviation 40.68
|
-37.44 percent change
Standard Deviation 31.97
|
-39.44 percent change
Standard Deviation 44.21
|
|
ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN)
ΔSUVpeak (Alive - Lung Cancer progression/death)
|
-39.15 percent change
Standard Deviation 49.02
|
-42.35 percent change
Standard Deviation 25.90
|
-37.55 percent change
Standard Deviation 57.54
|
|
ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN)
ΔSUVpeak (Lung Cancer progression/death)
|
-40.34 percent change
Standard Deviation 27.65
|
-34.88 percent change
Standard Deviation 35.71
|
-43.15 percent change
Standard Deviation 22.49
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔSUVpeak, as measured from Baseline to the During-treatment FDG PET/CT, will be assessed in its ability to predict Overall Survival (OS) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified ΔSUVpeak defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) OS defined as Alive 5 years post registration (Responders) OT defined as the ΔSUVpeak value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-34.71 percent change
Standard Deviation 53.230
|
-44.13 percent change
Standard Deviation 27.066
|
-29.21 percent change
Standard Deviation 63.707
|
|
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
-42.62 percent change
Standard Deviation 27.371
|
-34.43 percent change
Standard Deviation 34.126
|
-46.45 percent change
Standard Deviation 22.993
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔMTV, as measured from Baseline to the During-treatment FDG PET/CT, will be assessed in its ability to predict Overall Survival (OS) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified FDG ΔMTV defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) OS defined as Alive 5 years post registration (Responders) OT defined as the ΔMTV value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-34.27 percent change
Standard Deviation 37.955
|
-33.15 percent change
Standard Deviation 32.240
|
-34.92 percent change
Standard Deviation 41.578
|
|
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
53.59 percent change
Standard Deviation 719.072
|
-21.60 percent change
Standard Deviation 41.755
|
88.79 percent change
Standard Deviation 871.545
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FMISO Hypoxic tumor volume @baseline, will be assessed in its ability to predict Overall Survival (OS) 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 OS defined as Alive 5 years post registration (Responders) OT defined as the HV value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=23 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=9 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=14 Participants
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)
|
|---|---|---|---|
|
FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
19.88 cm^3
Standard Deviation 32.825
|
12.42 cm^3
Standard Deviation 15.385
|
24.36 cm^3
Standard Deviation 41.237
|
|
FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
34.76 cm^3
Standard Deviation 93.434
|
8.27 cm^3
Standard Deviation 9.533
|
52.43 cm^3
Standard Deviation 119.762
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
SUVmax, as measured at 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 LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the SUVmax value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=114 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=40 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=74 Participants
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)
|
|---|---|---|---|
|
FDG SUVmax @ Baseline FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
19.66 SUV
Standard Deviation 9.078
|
20.55 SUV
Standard Deviation 7.846
|
19.22 SUV
Standard Deviation 9.717
|
|
FDG SUVmax @ Baseline FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
17.42 SUV
Standard Deviation 9.021
|
14.57 SUV
Standard Deviation 7.901
|
19.06 SUV
Standard Deviation 9.306
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔSUVmax, as measured from Baseline to the During-treatment FDG PET/CT, 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 ΔSUVmax defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the ΔSUVmax value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-41.94 percent change
Standard Deviation 27.877
|
-39.55 percent change
Standard Deviation 25.183
|
-43.14 percent change
Standard Deviation 29.443
|
|
FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
-38.87 percent change
Standard Deviation 30.613
|
-32.87 percent change
Standard Deviation 39.834
|
-41.95 percent change
Standard Deviation 24.666
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔSUVpeak, as measured from Baseline to the During-treatment FDG PET/CT, 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 ΔSUVpeak defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the ΔSUVpeak value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-39.15 percent change
Standard Deviation 49.018
|
-42.35 percent change
Standard Deviation 25.898
|
-37.55 percent change
Standard Deviation 57.536
|
|
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
-40.34 percent change
Standard Deviation 27.651
|
-34.88 percent change
Standard Deviation 35.710
|
-43.15 percent change
Standard Deviation 22.486
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔMTV, as measured from Baseline to the During-treatment FDG PET/CT, 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 FDG ΔMTV defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the ΔMTV value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-33.56 percent change
Standard Deviation 40.690
|
-23.02 percent change
Standard Deviation 42.364
|
-38.83 percent change
Standard Deviation 39.445
|
|
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
67.91 percent change
Standard Deviation 777.403
|
-28.55 percent change
Standard Deviation 35.595
|
117.38 percent change
Standard Deviation 956.240
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
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
Outcome measures
| Measure |
Standard Radiation Therapy
n=23 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=9 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=14 Participants
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)
|
|---|---|---|---|
|
FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
18.08 cm^3
Standard Deviation 31.177
|
12.42 cm^3
Standard Deviation 15.385
|
20.91 cm^3
Standard Deviation 37.838
|
|
FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
36.98 cm^3
Standard Deviation 96.549
|
8.27 cm^3
Standard Deviation 9.533
|
58.52 cm^3
Standard Deviation 126.530
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
SUVmax, as measured at 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 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 SUVmax value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=114 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=40 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=74 Participants
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)
|
|---|---|---|---|
|
FDG SUVmax @ Baseline FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
21.44 SUV
Standard Deviation 6.966
|
22.10 SUV
Standard Deviation 6.810
|
20.96 SUV
Standard Deviation 7.368
|
|
FDG SUVmax @ Baseline FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
17.82 SUV
Standard Deviation 9.355
|
15.86 SUV
Standard Deviation 8.296
|
18.82 SUV
Standard Deviation 9.762
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔSUVmax, as measured from Baseline to the During-treatment FDG PET/CT, 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 ΔSUVmax defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) 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 ΔSUVmax value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
-39.86 percent change
Standard Deviation 29.948
|
-35.36 percent change
Standard Deviation 34.504
|
-42.01 percent change
Standard Deviation 27.573
|
|
FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-42.29 percent change
Standard Deviation 26.488
|
-37.85 percent change
Standard Deviation 33.387
|
-45.40 percent change
Standard Deviation 21.867
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔSUVpeak, as measured from Baseline to the During-treatment FDG PET/CT, 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 ΔSUVpeak defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) 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 ΔSUVpeak value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-46.89 percent change
Standard Deviation 26.280
|
-45.48 percent change
Standard Deviation 33.035
|
-47.87 percent change
Standard Deviation 22.308
|
|
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
-38.47 percent change
Standard Deviation 40.398
|
-36.44 percent change
Standard Deviation 31.496
|
-39.44 percent change
Standard Deviation 44.215
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
FDG ΔMTV, as measured from Baseline to the During-treatment FDG PET/CT, 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 FDG ΔMTV defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) 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 ΔMTV value corresponding to the maximum Youden index
Outcome measures
| Measure |
Standard Radiation Therapy
n=107 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=36 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=71 Participants
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)
|
|---|---|---|---|
|
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
-31.41 percent change
Standard Deviation 41.861
|
-34.95 percent change
Standard Deviation 33.445
|
-28.93 percent change
Standard Deviation 48.507
|
|
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
32.55 percent change
Standard Deviation 629.931
|
-23.96 percent change
Standard Deviation 39.584
|
59.42 percent change
Standard Deviation 765.244
|
SECONDARY outcome
Timeframe: Baseline to up to 5 yearsPopulation: Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed
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
Outcome measures
| Measure |
Standard Radiation Therapy
n=23 Participants
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=9 Participants
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.
|
Arm II (Experimental Chemoradiotherapy)
n=14 Participants
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)
|
|---|---|---|---|
|
FMISO Hypoxic Tumor Volume @Baseline, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Responder(No Event)
|
10.87 cm^3
Standard Deviation 13.104
|
14.82 cm^3
Standard Deviation 20.952
|
8.24 cm^3
Standard Deviation 9.901
|
|
FMISO Hypoxic Tumor Volume @Baseline, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
Non-Responder
|
34.79 cm^3
Standard Deviation 86.769
|
8.18 cm^3
Standard Deviation 8.706
|
51.72 cm^3
Standard Deviation 109.282
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to last follow-up.Population: The data required for this analysis was not obtained.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.Population: The data required for this analysis was not obtained.
Outcome measures
Outcome data not reported
Adverse Events
Standard Radiation Therapy
Serious events: 16 serious events
Other events: 42 other events
Deaths: 26 deaths
Adaptive Radiation Therapy
Serious events: 26 serious events
Other events: 83 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Standard Radiation Therapy
n=43 participants at risk
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Dysphagia
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Esophageal pain
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Esophagitis
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Chills
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Death NOS
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Fatigue
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Fever
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
General disorders and administration site conditions - Other
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Infusion related reaction
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Malaise
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Lung infection
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Tooth infection
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Upper respiratory infection
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Investigations - Other
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Lymphocyte count decreased
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Lymphocyte count increased
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Platelet count decreased
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
White blood cell decreased
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Stroke
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
0.00%
0/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
1.2%
1/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
Other adverse events
| Measure |
Standard Radiation Therapy
n=43 participants at risk
60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.
|
Adaptive Radiation Therapy
n=84 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
27.9%
12/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
29.8%
25/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
8/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
10.7%
9/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Alkaline phosphatase increased
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
9.5%
8/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Blood bilirubin increased
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
CD4 lymphocytes decreased
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Creatinine increased
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
20.2%
17/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Lymphocyte count decreased
|
39.5%
17/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
41.7%
35/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Neutrophil count decreased
|
23.3%
10/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
23.8%
20/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Platelet count decreased
|
39.5%
17/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
29.8%
25/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
Weight loss
|
25.6%
11/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
17.9%
15/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Investigations
White blood cell decreased
|
46.5%
20/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
44.0%
37/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.2%
13/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
34.5%
29/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.0%
6/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
23.8%
20/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.3%
10/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
28.6%
24/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
10.7%
9/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.3%
7/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
15.5%
13/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
10.7%
9/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.0%
6/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
19.0%
16/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
7/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
14.3%
12/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.3%
7/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
15.5%
13/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
17.9%
15/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
9.5%
8/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.3%
4/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Dizziness
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
23.8%
20/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Dysgeusia
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
15.5%
13/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Headache
|
9.3%
4/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
13.1%
11/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Paresthesia
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
8.3%
7/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
9.5%
8/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
51.2%
22/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
53.6%
45/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Psychiatric disorders
Anxiety
|
16.3%
7/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Psychiatric disorders
Confusion
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
6.0%
5/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Psychiatric disorders
Depression
|
9.3%
4/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
3.6%
3/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Psychiatric disorders
Insomnia
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
16.7%
14/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Renal and urinary disorders
Urinary frequency
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.5%
20/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
58.3%
49/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
51.2%
22/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
53.6%
45/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.0%
6/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.3%
7/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
14.3%
12/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
8.3%
7/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
6.0%
5/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.6%
8/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
21.4%
18/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
2.4%
2/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.6%
8/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
9.5%
8/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
7.1%
6/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Vascular disorders
Hot flashes
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
8.3%
7/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Dysphagia
|
44.2%
19/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
57.1%
48/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Esophageal pain
|
9.3%
4/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
8.3%
7/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Esophagitis
|
34.9%
15/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
56.0%
47/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.0%
3/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
8.3%
7/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Nausea
|
44.2%
19/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
47.6%
40/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
9/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
11.9%
10/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Chills
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
8.3%
7/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Edema limbs
|
2.3%
1/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
11.9%
10/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Fatigue
|
81.4%
35/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
78.6%
66/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Fever
|
14.0%
6/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
10.7%
9/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Gait disturbance
|
0.00%
0/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Non-cardiac chest pain
|
9.3%
4/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
10.7%
9/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
General disorders
Pain
|
14.0%
6/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
21.4%
18/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
46.5%
20/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
58.3%
49/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Cardiac disorders
Sinus tachycardia
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
10.7%
9/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
4.8%
4/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Constipation
|
41.9%
18/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
41.7%
35/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
14.0%
6/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
20.2%
17/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.6%
5/43 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
16.7%
14/84 • From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60