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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00107 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000721619 | |||
| ACRIN-6697 | Other Identifier | ACRIN | |
| RTOG-1106 | Other Identifier | NRG Oncology | |
| RTOG-1106 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source | |
| U10CA021661 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| NRG Oncology | OTHER |
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This randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT)-guided radiation therapy works compared to standard radiation therapy in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans, to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor and cause less damage to healthy tissue.
PRIMARY OBJECTIVES:
I. To determine whether tumor dose can be escalated to improve the freedom from local-regional progression-free (LRPF) rate at 2 years when an individualized adaptive radiation treatment (RT) plan is applied by the use of a fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan acquired during the course of fractionated RT in patients with inoperable stage III non-small cell lung cancer (NSCLC). (National Surgical Adjuvant Breast and Bowel Project [NSABP], Radiation Therapy Oncology Group [RTOG], Gynecologic Oncology Group [GOG] [NRG] Oncology) II. To determine whether the relative change in standard uptake value (SUV) peak from the baseline to the during-treatment FDG-PET/CT, defined as (during-treatment SUVpeak - baseline SUVpeak)/baseline SUV peak x 100%, can predict the LRPF rate with a 2-year follow up. (Eastern Cooperative Oncology Group [ECOG]-American College of Radiology Imaging Network [ACRIN])
SECONDARY OBJECTIVES:
I. To determine whether an individualized dose escalation improves overall survival (OS), progression-free survival (PFS), lung cancer cause-specific survival, and delays time to local-regional progression compared to a conventional RT plan. (NRG Oncology) II. To compare the rate of severe (grade 3+ Common Terminology Criteria for Adverse Events [CTCAE], v. 4) radiation-induced lung toxicity (RILT) defined as severe RILT pneumonitis or clinical fibrosis. (NRG Oncology) III. To compare other severe adverse events, including grade 3+ (CTCAE, v. 4) esophagitis or grade 2 pericardial effusions, or any grade cardiac adverse events related to chemoradiation between a PET/CT-guided adaptive approach and a conventional RT plan. (NRG Oncology) IV. To evaluate the association of baseline 18F-fluoromisonidazole (FMISO), a PET/CT imaging agent, uptake (tumor-to-blood pool ratio) with LRPF (i.e., the assessment of using baseline FMISO-PET uptake as a prognostic marker). (ECOG-ACRIN) V. To determine if the relative change in SUVpeak from baseline to during-treatment FDG-PET/CT and/or baseline FMISO uptake (tumor-to-blood pool ratio) predicts the differential benefit of the adaptive therapy, i.e., the association of uptake parameters with LRPF rate depending on the assigned treatment thus, assessing if these uptake parameters can be useful in guiding therapies, i.e., predictive markers. (ECOG-ACRIN) VI. To determine if other PET-imaging uptake parameters (SUV peak during-treatment for FDG-PET, maximum SUV, or relative change of maximum SUVs from pre- to during-treatment FDG-PET/CT, change in metabolic tumor volume, FMISO total hypoxic volume, FMISO tumor to mediastinum ratio, EORTC or University of Michigan/Kong's response criteria) will predict OS, LRPF rate, and lung cancer cause-specific (LCS) survival as well as to explore the optimal threshold for differentiating responders from non-responders. (ECOG-ACRIN)
CORRELATIVE SCIENCE OBJECTIVES:
I. To study whether a model of combining current clinical and/or imaging factors with blood markers, including osteopontin (OPN) [for hypoxia marker], carcinoembryonic antigen (CEA) and cytokeratin fragment (CYFRA) 21-1 (for tumor burden), and interleukin (IL)-6 (inflammation) will predict the 2-year LRPF rate and survival better than a current model using clinical factors and radiation dose as well as imaging factors.
II. To determine/validate whether a model of combining mean lung dose (MLD), transforming growth factor beta1 (TGF beta1) and IL-8 will improve the predictive accuracy for clinical significant RILT better comparing to the current model of using MLD alone.
III. To explore, in a preliminary manner, whether proteomic and genomic markers in the blood prior to and during the early course of treatment are associated with tumor response after completion of treatment, LRPF rate, PFS, OS, and pattern of failure and treatment-related adverse events, such as radiation pneumonitis, esophagitis, and pericardial effusion. (exploratory)
OUTLINE:
Prior to treatment, patients undergo fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and computed tomography (CT) scans at baseline and periodically during study. A subset of patients also undergo 18F-fluoromisonidazole PET/CT scan at baseline. Patients are randomized to 1 of 2 treatment arms:
ARM I (standard chemoradiotherapy): Patients undergo radiotherapy once daily (QD) 5 days a week for 30 fractions. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FDG-PET/CT imaging 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.
CONSOLIDATION CHEMOTHERAPY: Beginning 4-6 weeks after chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard chemoradiotherapy) | Active Comparator | Patients undergo radiotherapy QD 5 days a week for 30 fractions. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FDG-PET/CT imaging between fractions 18 and 19. |
|
| Arm II (experimental chemoradiotherapy) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluoromisonidazole | Drug | Undergo FMISO PET/CT (Correlative studies) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG) | 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:
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. | Randomization to 2 years |
| 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) | 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 | Baseline to during-treatment (approximately between fractions 18-19) Randomization to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local-regional Progression (NRG) | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify Relationship Between Biomarkers and Grade 2+ Radiation-induced Lung Toxicity [RILT] (NRG) | Randomization to last follow-up. | |
| Quantify Relationship Between Biomarkers and Two-year Local-regional Progression-free (LRPF) Survival (NRG) | 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. |
Inclusion Criteria:
Exclusion Criteria:
Patients with any component of small cell lung carcinoma are excluded
Patients with evidence of a malignant pleural or pericardial effusion are excluded
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active co-morbidity, defined as follows:
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians
Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded
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| Name | Affiliation | Role |
|---|---|---|
| Feng-Ming (Spring) P Kong | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | United States | ||
| Augusta University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39365957 | Derived | Kong FS, Hu C, Pryma DA, Duan F, Matuszak M, Xiao Y, Ten Haken R, Siegel MJ, Hanna L, Curran WJ, Dunphy M, Gelblum D, Piert M, Jolly S, Robinson CG, Quon A, Loo BW, Srinivas S, Videtic GM, Faria SL, Ferguson C, Dunlap NE, Kundapur V, Paulus R, Siegel BA, Bradley JD, Machtay M. Primary Results of NRG-RTOG1106/ECOG-ACRIN 6697: A Randomized Phase II Trial of Individualized Adaptive (chemo)Radiotherapy Using Midtreatment 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Stage III Non-Small Cell Lung Cancer. J Clin Oncol. 2024 Nov 20;42(33):3935-3946. doi: 10.1200/JCO.24.00022. Epub 2024 Oct 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Radiation Therapy | 60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2018 |
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| Carboplatin | Drug | Given IV |
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| Computed Tomography | Procedure | Undergo FDG PET/CT |
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| Computed Tomography | Procedure | Undergo FMISO PET/CT (Correlative studies) |
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| External Beam Radiation Therapy | Radiation | Undergo radiotherapy |
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| Fludeoxyglucose F-18 | Drug | Undergo FDG PET/CT |
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| Image-Guided Adaptive Radiation Therapy | Radiation | Undergo individualized adaptive radiotherapy |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Paclitaxel | Drug | Given IV |
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| Positron Emission Tomography | Procedure | Undergo FDG PET/CT |
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| Positron Emission Tomography | Procedure | Undergo FMISO PET/CT (Correlative studies) |
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| 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. |
| Percentage of Participants Alive (Overall Survival) (NRG) | 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. | 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. |
| Percentage of Participants Alive Without Progression (Progression-free Survival) (NRG) | 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. | 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. |
| Percentage of Participants With Death Due to Lung Cancer (NRG) | 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. | 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. |
| Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG) | RILT is defined as clinical radiation pneumonitis and clinical fibrosis. Grading is defined in the protocol as follows (grade 3 and higher):
| 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. |
| Percentage of Participants With Grade 3+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events at Any Time (NRG) | 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. | 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. |
| Baseline 18F-fluoromisonidazole (FMISO) Uptake (Tumor-to-blood Pool Ratio) Measures Association With LRPF 2-years Post Registration (ECOG-ACRIN) | 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) | Baseline and 2-years after randomization |
| Baseline 18F-fluoromisonidazole (FMISO) Tumor Hypoxic Volume Association With LRPF 2-years Post Registration (ECOG-ACRIN) | 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 | Baseline and 2-years after randomization |
| 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) | 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 | Baseline to up to 5 years after randomization |
| SUVmax at Baseline Prediction of OS and Optimal Threshold (ECOG-ACRIN) | FDG SUVmax as measured at baseline PET imaging will be assessed in its ability to predict Overall Survival (OS) at year 5. | Baseline to up to 5 years |
| FDG ΔSUVmax, From Baseline to the During-treatment FDG PET/CT, to Predict OS and Optimal Threshold (ECOG-ACRIN) | 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. | Baseline to up to 5 years |
| ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN) | 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. | Up to 5 years |
| FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG SUVmax @ Baseline FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG SUVmax @ Baseline FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| FMISO Hypoxic Tumor Volume @Baseline, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Baseline to up to 5 years |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Sleepy Hollow | Sleepy Hollow | New York | 10591 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Cleveland Clinic Cancer Center Independence | Independence | Ohio | 44131 | United States |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | United States |
| Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | 44136 | United States |
| Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | 44691 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| McGill University Department of Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Eligible |
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| Eligible and Started Study Treatment |
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| Eligible With Radiation-induced Lung Toxicity |
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| COMPLETED | Participants contributing data to results are considered to have completed the study |
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| NOT COMPLETED |
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Eligible participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Radiation Therapy | 60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Zubrod Performance Status | 0 - Asymptomatic; 1 - Symptomatic but completely ambulatory; 2 - Symptomatic, <50% in bed during the day; 3 - Symptomatic, >50% in bed, but not bedbound; 4 - Bedbound; 5 - Death | Count of Participants | Participants |
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| Histology | Count of Participants | Participants |
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| Histology | Count of Participants | Participants |
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| AJCC Stage | Overall cancer stage per American Joint Committee on Cancer (AJCC) 7th ed. combines tumor (T), regional lymph node (N), and distant metastasis (M) staging to determine an overall stage of 0, I, II, III, or IV, ranging from least to most advanced, respectively. Stage IIIA: (T1-2,N2,M0) or (T3,N1-2,M0) or (T4,N0-1,M0); Stage IIIB: (T1-T3,N3,M0) or (T4,N2-3,M0). The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. The higher the number after the N, the greater the involvement of regional lymph nodes. M0 indicates no distant metastasis. | Count of Participants | Participants |
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| Primary Tumor size | Count of Participants | Participants |
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| Smoking history | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG) | 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:
LRPF-free survival time is defined as time from registration to the date of first local-regional progression, distant recurrence (censored), death without documented LRP (censored), or death. LRPF survival rates are estimated using the Kaplan-Meier method. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to 2 years |
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| Primary | 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) | To determine whether the relative change in SUVpeak (from the baseline to the during-treatment FDG-PET/CT) can predict the LRPF with a 2-year follow up. Relative ΔSUVpeak = (Mid-treatment SUVpeak - baseline SUVpeak)/baseline SUVpeak x 100 LRPF was determined from Randomization up to 2 years | All cases with both baseline and during-treatment FDG-PET/CT scans | Posted | Mean | Standard Deviation | percent change | Baseline to during-treatment (approximately between fractions 18-19) Randomization to 2 years |
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| Secondary | Percentage of Participants With Local-regional Progression (NRG) | 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:
LRP time is defined as time from randomization to the date of first LRP, distant metastasis without LRP (competing risk), death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants Alive (Overall Survival) (NRG) | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants Alive Without Progression (Progression-free Survival) (NRG) | Progression is defined as the first of the following: local, regional, distant progression, or death due to any cause. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Two-year estimates are provided. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants With Death Due to Lung Cancer (NRG) | A lung cancer death is defined as cause of death designated as lung cancer or death with any evidence of disease progression at any site without a direct evidence of other cause of death. Time to lung cancer death is defined as time from randomization to the date of lung cancer death, last known follow-up (censored), or death without lung cancer (competing risk). Lung cancer death rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG) | RILT is defined as clinical radiation pneumonitis and clinical fibrosis. Grading is defined in the protocol as follows (grade 3 and higher):
| Eligible participants with RILT data. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants With Grade 3+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events at Any Time (NRG) | 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. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Baseline 18F-fluoromisonidazole (FMISO) Uptake (Tumor-to-blood Pool Ratio) Measures Association With LRPF 2-years Post Registration (ECOG-ACRIN) | 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) | Participants enrolled at an institution participating in the FMISO Correlative Study. Note that the company supplying FMISO ceased production early in the study. | Posted | Mean | Standard Deviation | SUV | Baseline and 2-years after randomization |
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| Secondary | Baseline 18F-fluoromisonidazole (FMISO) Tumor Hypoxic Volume Association With LRPF 2-years Post Registration (ECOG-ACRIN) | 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 | Participants enrolled at an institution participating in the FMISO Correlative Study. Note that the company supplying FMISO ceased production early in the study. | Posted | Mean | Standard Deviation | cm^3 | Baseline and 2-years after randomization |
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| Secondary | 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) | 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 | 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 | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years after randomization |
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| Secondary | SUVmax at Baseline Prediction of OS and Optimal Threshold (ECOG-ACRIN) | FDG SUVmax as measured at baseline PET imaging will be assessed in its ability to predict Overall Survival (OS) at year 5. | 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 | Posted | Mean | Standard Deviation | SUV | Baseline to up to 5 years |
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| Secondary | FDG ΔSUVmax, From Baseline to the During-treatment FDG PET/CT, to Predict OS and Optimal Threshold (ECOG-ACRIN) | 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. | 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 | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN) | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Up to 5 years |
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| Secondary | FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | cm^3 | Baseline to up to 5 years |
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| Secondary | FDG SUVmax @ Baseline FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | SUV | Baseline to up to 5 years |
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| Secondary | FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | cm^3 | Baseline to up to 5 years |
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| Secondary | FDG SUVmax @ Baseline FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | SUV | Baseline to up to 5 years |
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| Secondary | FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | percent change | Baseline to up to 5 years |
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| Secondary | FMISO Hypoxic Tumor Volume @Baseline, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN) | 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 | Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed | Posted | Mean | Standard Deviation | cm^3 | Baseline to up to 5 years |
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| Other Pre-specified | Quantify Relationship Between Biomarkers and Grade 2+ Radiation-induced Lung Toxicity [RILT] (NRG) | The data required for this analysis was not obtained. | Posted | Randomization to last follow-up. |
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| Other Pre-specified | Quantify Relationship Between Biomarkers and Two-year Local-regional Progression-free (LRPF) Survival (NRG) | The data required for this analysis was not obtained. | Posted | 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. |
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From randomization to last follow-up. Maximum follow-up at time of reporting was 7.3 years.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Radiation Therapy | 60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. | 26 | 43 | 16 | 43 | 42 | 43 |
| EG001 | 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. | 51 | 84 | 26 | 84 | 83 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Esophageal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| General disorders and administration site conditions - Other | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Infusion related reaction | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Malaise | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Bronchial infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
The primary endpoint was designed assuming centrally reviewed progression. However, the protocol did not require submission of off-schedule CT scans which may have been used by the site for determination of progression. As a result, not all instances of progression could be centrally reviewed. For these instances, the site determination of progression was used for the primary endpoint.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 215-574-3208 | seiferheldw@nrgoncology.org |
| Nov 20, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C031843 | fluoromisonidazole |
| D016190 | Carboplatin |
| D011827 | Radiation |
| D019788 | Fluorodeoxyglucose F18 |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D055585 | Physical Phenomena |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| 50 - 59 years |
|
| 60 - 69 years |
|
| ≥ 70 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| Adenocarcinoma |
|
| Large cell undifferentiated |
|
| Non-small-cell lung cancer not otherwise specified (NSCLC NOS) |
|
| Adenosquamous |
|
| Squamous |
|
| IIIB |
|
| > 5 cm |
|
| Former smoker, ≤ 10 pack years |
|
| Former smoker, > 10 pack years |
|
| Current smoker |
|
| Unknown |
|
| Units | Counts |
|---|---|
| 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. |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| 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. |
|
|
|
| Participants |
|
|
|
| OG002 | 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) |
|
|
|
| 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) |
|
|
|
| OG002 | 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) |
|
|
|
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) |
|
|
|
| OG002 | 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) |
|
|
|
| OG002 | 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) |
|
|
| OG002 | 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) |
|
|
|
| OG002 | 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) |
|
|
|
| OG002 | 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) |
|
|
|
| OG002 | 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) |
|
|
|
| OG002 | 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) |
|
|
|
| OG002 | 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) |
|
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| OG002 | 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) |
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| OG002 | 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) |
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| OG002 | 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) |
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| OG002 | 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) |
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| OG002 | 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) |
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| OG002 | 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) |
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| OG002 | 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) |
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