FLARE RT for Patients With Stage IIB-IIIB Non-small Cell Lung Cancer: Personalizing Radiation Therapy Using PET/CT and SPECT/CT Imaging

NCT02773238 | Completed Phase 2 Results DMC

• 4 other identifiers: 9599NCI-2016-00543R01CA204301RG3116002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

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

Stage IIB Lung Non-Small Cell Carcinoma AJCC v7; Stage IIIA Lung Non-Small Cell Cancer AJCC v7; Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) Rate

  Final statistical analyses of OS will consist of Kaplan-Meier estimation.

  At 2 years

Secondary Outcomes (5)

• Radiation Pneumonitis Defined as Common Terminology Criteria for Adverse Events Version 4 Grade 2 or Higher Pneumonitis

  Up to 3 months

• Local-Regional Progression as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria

  At 1 year

• Progression-free Survival (PFS)

  1 year

• Change in Pulmonary Function-forced Expiratory Volume in 1 Second (FEV1)

  Baseline to 3 months post-radiation therapy

• Change in Pulmonary Function (Diffusing Capacity of the Lungs for Carbon Monoxide [DLCO])

  Baseline to 3 months post-radiation therapy

Study Arms (1)

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.

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

Interventions

Computed Tomography PROCEDURE

Undergo FDG PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Treatment

Fludeoxyglucose F-18 RADIATION

Undergo FDG PET/CT

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Treatment

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment

Positron Emission Tomography PROCEDURE

Undergo FDG PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Treatment

Radiation Therapy RADIATION

Undergo functional avoidance radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, RADIATION, Radiotherapeutics, radiotherapy, RT, Therapy, Radiation

Treatment

Single Photon Emission Computed Tomography PROCEDURE

Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT

Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

Treatment

Technetium Tc-99m Albumin Aggregated RADIATION

Undergo Tc-99m MAA SPECT/CT

Also known as: Tc 99m-labeled MAA, Technetium Tc 99m-Labeled Macroaggregated Albumin

Treatment

Technetium Tc-99m Sulfur Colloid RADIATION

Undergo Tc-99m sulfur colloid

Also known as: Tc 99m sulfur colloid, Tc-99m SC, technetium Tc 99m sulfur colloid

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

SCCA Proton Therapy Center

Seattle, Washington, 98133, United States

Location

Related Publications (4)

• 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.

  PMID: 38981590 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.

  PMID: 34172602 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.

  PMID: 33027064 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.

  PMID: 31142507 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; Radiotherapy; Radiation; X-Rays; Photons; Technetium Tc 99m Aggregated Albumin; Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Therapeutics; Physical Phenomena; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing; Organotechnetium Compounds; Organometallic Compounds; Organic Chemicals; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Results Point of Contact

• Title: Dr. Jing Zeng
• Organization: University of Washington

jzeng13@uw.edu

206-598-4110

Study Officials

• Jing Zeng

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 16, 2016
• Study Start: May 20, 2016
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)