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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00543 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9599 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA204301 | U.S. NIH Grant/Contract | View source | |
| RG3116002 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer. PET/CT imaging mid-way through treatment may be able to accurately show how well radiation therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the lung tissue are healthier than others. Based on the result of the imaging, treatment adjustments may be made to the radiation therapy to improve survival and decrease toxicity.
OUTLINE: This is a dose-escalation study of radiation therapy.
Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage.
After completion of study treatment, patients are followed up for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo FDG PET/CT |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Rate | Final statistical analyses of OS will consist of Kaplan-Meier estimation. | At 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Pneumonitis Defined as Common Terminology Criteria for Adverse Events Version 4 Grade 2 or Higher Pneumonitis | Common Terminology Criteria for Adverse Events version 4, grade 2 or higher pneumonitis is defined as breathing problems after radiation treatment requiring medications for treatment (grade 2), oxygen use (grade 3), hospitalization (grade 4), or leading to death (grade 5). Clinical studies commonly report how many patients that develop pneumonitis as a result of radiation treatment, which is usually within the first 3 months after radiation. |
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Inclusion Criteria:
Pathologically proven (either histologic or cytologic) diagnosis of stage IIB-IIIB non-small cell lung cancer (NSCLC); according to American Joint Committee on Cancer (AJCC) staging, 7th edition
Patients must be considered unresectable or inoperable
Patient must not have received prior radiation for this lung cancer
Patients must be having concurrent chemotherapy
Nodal recurrences can be treated on this protocol but prior curative surgery for lung cancer must have been at least 6 months prior to the nodal recurrence
Patients must have measurable or evaluable disease that is FDG avid with standardized uptake value (SUV) > 3 on PET/CT
Zubrod performance status 0-1
PFTs including forced expiratory volume in 1 second (FEV1) within 26 weeks prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 0.8 liters/second or >= 50% predicted
Blood cell count (CBC)/differential obtained within 8 weeks prior to registration on study
Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
Platelets >= 100,000 cells/mm^3
Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
Serum creatinine within normal institutional limits or creatinine clearance >= 40 ml/min
Bilirubin must be within or below normal institutional limits
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x the institutional upper limit of normal (IULN)
Patient must sign study specific informed consent prior to study entry
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zeng | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States | ||
| SCCA Proton Therapy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38981590 | Derived | Duan C, Liu Q, Wang J, Tong Q, Bai F, Han J, Wang S, Hippe DS, Zeng J, Bowen SR. GWO+RuleFit: rule-based explainable machine-learning combined with heuristics to predict mid-treatment FDG PET response to chemoradiation for locally advanced non-small cell lung cancer. Phys Med Biol. 2024 Jul 23;69(15):10.1088/1361-6560/ad6118. doi: 10.1088/1361-6560/ad6118. | |
| 34172602 | Derived | Horn KP, Thomas HMT, Vesselle HJ, Kinahan PE, Miyaoka RS, Rengan R, Zeng J, Bowen SR. Reliability of Quantitative 18F-FDG PET/CT Imaging Biomarkers for Classifying Early Response to Chemoradiotherapy in Patients With Locally Advanced Non-Small Cell Lung Cancer. Clin Nucl Med. 2021 Nov 1;46(11):861-871. doi: 10.1097/RLU.0000000000003774. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage. Computed Tomography: Undergo FDG PET/CT Computed Tomography: Undergo Tc-99m MAA or Tc-99m DTPA Fludeoxyglucose F-18: Undergo FDG PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FDG PET/CT Radiation Therapy: Undergo functional avoidance radiation therapy Single Photon Emission Computed Tomography: Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT Technetium Tc-99m Albumin Aggregated: Undergo Tc-99m MAA SPECT/CT Technetium Tc-99m Sulfur Colloid: Undergo Tc-99m sulfur colloid |
| 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 | Jan 26, 2024 |
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| Computed Tomography | Procedure | Undergo Tc-99m MAA or Tc-99m DTPA |
|
|
| Fludeoxyglucose F-18 | Radiation | Undergo FDG PET/CT |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Positron Emission Tomography | Procedure | Undergo FDG PET/CT |
|
|
| Radiation Therapy | Radiation | Undergo functional avoidance radiation therapy |
|
|
| Single Photon Emission Computed Tomography | Procedure | Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT |
|
|
| Technetium Tc-99m Albumin Aggregated | Radiation | Undergo Tc-99m MAA SPECT/CT |
|
|
| Technetium Tc-99m Sulfur Colloid | Radiation | Undergo Tc-99m sulfur colloid |
|
|
| Up to 3 months |
| Local-Regional Progression as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria | Intrathoracic progression of lung tumors assessed by post-radiotherapy computed tomography. Progression will be defined by RECIST criteria. Final statistical analyses of local-regional progression cumulative incidence will consist of Fine-Gray estimation with death and distant metastasis as competing risks. | At 1 year |
| Progression-free Survival (PFS) | Progression-free survival will be assessed by post-radiotherapy computed tomography. Progression will be defined by RECIST criteria. Final statistical analyses of PFS will consist of Kaplan-Meier estimation. | 1 year |
| Change in Pulmonary Function-forced Expiratory Volume in 1 Second (FEV1) | Pulmonary function tests (FEV1, liters) will be performed and change over time will be evaluated. | Baseline to 3 months post-radiation therapy |
| Change in Pulmonary Function (Diffusing Capacity of the Lungs for Carbon Monoxide [DLCO]) | Pulmonary function tests (DLCO, % predicted) will be performed and change over time will be evaluated. | Baseline to 3 months post-radiation therapy |
| Seattle |
| Washington |
| 98133 |
| United States |
| 33027064 | Derived | Duan C, Chaovalitwongse WA, Bai F, Hippe DS, Wang S, Thammasorn P, Pierce LA, Liu X, You J, Miyaoka RS, Vesselle HJ, Kinahan PE, Rengan R, Zeng J, Bowen SR. Sensitivity analysis of FDG PET tumor voxel cluster radiomics and dosimetry for predicting mid-chemoradiation regional response of locally advanced lung cancer. Phys Med Biol. 2020 Oct 7;65(20):205007. doi: 10.1088/1361-6560/abb0c7. |
| 31142507 | Derived | Bowen SR, Hippe DS, Chaovalitwongse WA, Duan C, Thammasorn P, Liu X, Miyaoka RS, Vesselle HJ, Kinahan PE, Rengan R, Zeng J. Voxel Forecast for Precision Oncology: Predicting Spatially Variant and Multiscale Cancer Therapy Response on Longitudinal Quantitative Molecular Imaging. Clin Cancer Res. 2019 Aug 15;25(16):5027-5037. doi: 10.1158/1078-0432.CCR-18-3908. Epub 2019 May 29. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage. Computed Tomography: Undergo FDG PET/CT Computed Tomography: Undergo Tc-99m MAA or Tc-99m DTPA Fludeoxyglucose F-18: Undergo FDG PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FDG PET/CT Radiation Therapy: Undergo functional avoidance radiation therapy Single Photon Emission Computed Tomography: Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT Technetium Tc-99m Albumin Aggregated: Undergo Tc-99m MAA SPECT/CT Technetium Tc-99m Sulfur Colloid: Undergo Tc-99m sulfur colloid |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) Rate | Final statistical analyses of OS will consist of Kaplan-Meier estimation. | Posted | Number | 95% Confidence Interval | percentage of patients | At 2 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Radiation Pneumonitis Defined as Common Terminology Criteria for Adverse Events Version 4 Grade 2 or Higher Pneumonitis | Common Terminology Criteria for Adverse Events version 4, grade 2 or higher pneumonitis is defined as breathing problems after radiation treatment requiring medications for treatment (grade 2), oxygen use (grade 3), hospitalization (grade 4), or leading to death (grade 5). Clinical studies commonly report how many patients that develop pneumonitis as a result of radiation treatment, which is usually within the first 3 months after radiation. | Posted | Count of Participants | Participants | Up to 3 months |
| |||||||||||||||||||||||||||||
| Secondary | Local-Regional Progression as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria | Intrathoracic progression of lung tumors assessed by post-radiotherapy computed tomography. Progression will be defined by RECIST criteria. Final statistical analyses of local-regional progression cumulative incidence will consist of Fine-Gray estimation with death and distant metastasis as competing risks. | Posted | Number | 95% Confidence Interval | percentage of patients | At 1 year |
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Progression-free survival will be assessed by post-radiotherapy computed tomography. Progression will be defined by RECIST criteria. Final statistical analyses of PFS will consist of Kaplan-Meier estimation. | Posted | Number | 95% Confidence Interval | percentage of patients | 1 year |
| ||||||||||||||||||||||||||||
| Secondary | Change in Pulmonary Function-forced Expiratory Volume in 1 Second (FEV1) | Pulmonary function tests (FEV1, liters) will be performed and change over time will be evaluated. | 51 patient had pre-radiation PFTs done, but only 45 patients had 3-months post-radiation PFTs performed. Patients either withdrew from study due to cancer progression or declined the repeat testing. | Posted | Mean | Standard Deviation | liters | Baseline to 3 months post-radiation therapy |
| |||||||||||||||||||||||||||
| Secondary | Change in Pulmonary Function (Diffusing Capacity of the Lungs for Carbon Monoxide [DLCO]) | Pulmonary function tests (DLCO, % predicted) will be performed and change over time will be evaluated. | Only 45 patients went through both baseline and 3-months post-radiation testing. | Posted | Mean | Standard Deviation | percentage of predicted lung function | Baseline to 3 months post-radiation therapy |
|
Adverse events were collected during radiation treatment weekly during physician visits, and then monthly after radiation treatment was completed for 3 months.
CTCAE v4 was used to grade adverse events for up to 3 months after completion of radiation. Survival was monitored for up to 2 years after end of radiation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage. Computed Tomography: Undergo FDG PET/CT Computed Tomography: Undergo Tc-99m MAA or Tc-99m DTPA Fludeoxyglucose F-18: Undergo FDG PET/CT Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo FDG PET/CT Radiation Therapy: Undergo functional avoidance radiation therapy Single Photon Emission Computed Tomography: Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT Technetium Tc-99m Albumin Aggregated: Undergo Tc-99m MAA SPECT/CT Technetium Tc-99m Sulfur Colloid: Undergo Tc-99m sulfur colloid | 24 | 51 | 6 | 51 | 49 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis Grade 3+ | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Esophagitis Grade 3+ | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Esophagitis Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dermatitis Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fatigue Grade 2 | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing Zeng | University of Washington | 206-598-4110 | jzeng13@uw.edu |
| May 27, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D014965 | X-Rays |
| D017785 | Photons |
| D013668 | Technetium Tc 99m Aggregated Albumin |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D011839 | Radiation, Ionizing |
| D004601 | Elementary Particles |
| D008027 | Light |
| D055620 | Optical Phenomena |
| D011840 | Radiation, Nonionizing |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
| D009930 | Organic Chemicals |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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