FLARE RT for Patients With Stage IIB-IIIB Non-small Cell Lung Cancer: Personalizing Radiation Therapy Using PET/CT and SPECT/CT Imaging
NCT ID: NCT02773238
Last Updated: 2024-08-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2016-05-20
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
NCT00564733
A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC
NCT00963807
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
NCT01218516
Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial
NCT02002052
FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy
NCT04491084
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Staging workup must include: brain imaging (CT head or magnetic resonance imaging \[MRI\] brain) and PET/CT
* Pleural effusions must have cytology to rule out malignant involvement unless too small to undergo thoracentesis per radiology
* 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
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jing Zeng
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jing Zeng
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
SCCA Proton Therapy Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-00543
Identifier Type: REGISTRY
Identifier Source: secondary_id
9599
Identifier Type: OTHER
Identifier Source: secondary_id
RG3116002
Identifier Type: OTHER
Identifier Source: secondary_id
9599
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.