Clinical trial · Interventional
FLARE RT for Patients With Stage IIB-IIIB Non-small Cell Lung Cancer: Personalizing Radiation Therapy Using PET/CT and SPECT/CT Imaging
Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | — | UNRESOLVED | — |
| Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Fludeoxyglucose F-18 | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Single Photon Emission Computed Tomography | Procedure | — | UNRESOLVED |
| Technetium Tc-99m Albumin Aggregated | Radiation | — | UNRESOLVED |
| Technetium Tc-99m Sulfur Colloid | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Radiation: Fludeoxyglucose F-18
- Other: Laboratory Biomarker Analysis
- Procedure: Positron Emission Tomography
- Radiation: Radiation Therapy
- Procedure: Single Photon Emission Computed Tomography
- Radiation: Technetium Tc-99m Albumin Aggregated
- Radiation: Technetium Tc-99m Sulfur Colloid
Primary outcomes (1)
- measure
- Overall Survival (OS) Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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: * \> 10% unintentional weight loss within the past month * 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
References
Publications (4)
- DERIVEDDuan 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. PMID 38981590
- DERIVEDHorn 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. PMID 34172602
- DERIVEDDuan 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. PMID 33027064
- DERIVEDBowen 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. PMID 31142507