Non-Small Cell Lung CancerNCT02843568
Improving Pulmonary Function Following Radiation Therapy
A study testing Laboratory Biomarker Analysis, Standard fractionation and Stereotactic Body Radiation Therapy (SBRT) in people with Non-Small Cell Lung Cancer, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The purpose of this study is to develop radiation plans that will help preserve lung function in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in designing radiation treatment plans that help us avoid healthy normal functioning lung tissue close to lung tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Laboratory Biomarker Analysis, Standard fractionation and Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2016to 16 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of non-small cell lung cancer or lung metastasis from a solid tumor. One biopsy site is adequate for multiple sites of thoracic disease.
- Treatment includes localized radiation therapy with or without chemotherapy
- Karnofsky ≥ 60%
- Not pregnant per radiation oncology standard procedures
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer
- Prior thoracic radiotherapy
- Severe COPD defined as disease requiring an inpatient stay for respiratory deterioration within the past 3 months
- Oxygen dependence of > 2 L/min continuously throughout the day at baseline
- Known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UW Johnson Creek
Johnson Creek, Wisconsin, 53038
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
The purpose of this study is to develop radiation plans that will help preserve lung function in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in designing radiation treatment plans that help us avoid healthy normal functioning lung tissue close to lung tumors. Currently 4DCT scans are used to help us determine exactly where the tumor is and how it moves when you breathe. In this study we will also use the 4DCT scans to try to identify high functioning normal lung tissue.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Laboratory Biomarker Analysis, Standard fractionation, Stereotactic Body Radiation Therapy (SBRT), Four Dimensional Computed Tomographic Imaging (4DCT)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Standard fractionationRadiation
Also called Cancer Radiotherapy, Radiation
60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called SBRT, Cancer Radiotherapy, Radiation
40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT)Procedure or surgery
Also called 4DCT
Subjects undergo a total of 7 research-ordered four dimensional computed tomographic imaging (4DCT) scans: 1 at simulation, and 2 scans at each of the 3 post-radiation therapy time points (3, 6, and 12 months). 4DCT determines lung tissue elasticity and for standard of care radiation treatment planning.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Subjects undergo four-dimensional computed tomographic imaging (4DCT) scans: 1 at simulation, and 2 scans at each of the 3 post-radiation therapy time points (3, 6, and 12 months). 4DCT determines lung tissue elasticity and for standard of care radiation treatment planning. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care. Receives: Other: Laboratory Biomarker Analysis; Radiation: Standard fractionation; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Four Dimensional Computed Tomographic Imaging (4DCT) |
| Pulmonary Function Damage Reduction | Experimental | All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged. Receives: Other: Laboratory Biomarker Analysis; Radiation: Standard fractionation; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Four Dimensional Computed Tomographic Imaging (4DCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT
The primary endpoint of this study will be the ratio of the tissue elasticity map following RT to the elasticity map before RT (i.e., the Jacobian ratio of (post RT /pre RT)) calculated from 4DCT at 3 months post-RT. Based on the randomness of our measurement technique, diminished expansion (i.e. substantial change) is defined as a Jacobian ratio <0.94 (i.e., less than 94% of the pre-RT value).
Measured: 3 months post RT
Secondary outcomes (9)
Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)
Changes in Reduced Elasticity (defined as < 0.94*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: During therapy to 12 months post-RT
Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)
Changes in Reduced Elasticity (defined as < 0.94*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: During therapy to 12 months post-RT
Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)
Changes in Increased Elasticity (defined as > 1.06*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: During therapy to 12 months post-RT
Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)
Changes in Increased Elasticity (defined as > 1.06*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: During therapy to 12 months post-RT
Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Percent Change)
Changes in Expansion of Lung Determined by the Volume of Lung Where "Meaningful" Expansion (defined as > 1.1*median ) Occurs (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: During therapy to 12 months post-RT
Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Ratio)
Changes in Expansion of Lung Determined by the Volume of Lung Where "Meaningful" Expansion (defined as > 1.1*median ) Occurs (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: During therapy to 12 months post-RT
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median absolute change in the percent predicted following pulmonary function tests reported: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and diffusing capacity of carbon monoxide (DLCO). All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: Pre-RT up to 12 months post-RT
Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves
All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: Up to 12 months post-RT
Variation of the Tissue Elasticity Calculated Between Scan 1 and Scan 2 at Each Time Point Will be Quantified and Compared to Longitudinal Changes in Tissue Elasticity
All statistical tests will be two-sided and assessed for significance at the 5% level.
Measured: Up to 12 months post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start17 Aug 2016
- Primary completion28 Oct 2022
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carri K Glide-Hurst, PhD, DABR, FAAPM, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843568
- Sponsor's protocol ID
- 2016-0610
- Other IDs
- NCI-2016-01085, UW16037, A539933, SMPH\VOLUNTEER STAFF\HUM ONCOL, Protocol Version 6/9/2022, R01CA166703
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2016
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Baschnagel AM, Flakus MJ, Wallat EM, Wuschner AE, Chappell RJ, Bayliss RA, Kimple RJ, Christensen GE, Reinhardt JM, Bassetti MF, Bayouth JE. A Phase 2 Randomized Clinical Trial Evaluating 4-Dimensional Computed Tomography Ventilation-Based Functional Lung Avoidance Radiation Therapy for Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1393-1402. doi: 10.1016/j.ijrobp.2024.02.019. Epub 2024 Feb 20.
PubMed 38387810
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pulmonary Function Following Radiation Therapy
- ClinicalTrials.gov ID
- NCT02843568
- Acronym / sponsor ID
- 2016-0610
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop radiation plans that will help preserve lung function in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in designing radiation treatment plans that help us avoid healthy normal functioning lung tissue close to lung tumors. Currently 4DCT scans are used to help us determine exactly where the tumor is and how it moves when you breathe. In this study we will also use the 4DCT scans to try to identify high functioning normal lung tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Laboratory Biomarker Analysis, Radiation: Standard fractionation, Radiation: Stereotactic Body Radiation Therapy (SBRT), Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)Subjects undergo four-dimensional computed tomographic imaging (4DCT) scans: 1 at simulation, and 2 scans at each of the 3 post-radiation therapy time points (3, 6, and 12 months). 4DCT determines lung tissue elasticity and for standard of care radiation treatment planning. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment. Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care. |
| Pulmonary Function Damage Reduction | Experimental | Other: Laboratory Biomarker Analysis, Radiation: Standard fractionation, Radiation: Stereotactic Body Radiation Therapy (SBRT), Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic diagnosis of non-small cell lung cancer or lung metastasis from a solid tumor. One biopsy site is adequate for multiple sites of thoracic disease.
- Treatment includes localized radiation therapy with or without chemotherapy
- Karnofsky ≥ 60%
- Not pregnant per radiation oncology standard procedures
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (6 listed)
- Prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer
- Prior thoracic radiotherapy
- Severe COPD defined as disease requiring an inpatient stay for respiratory deterioration within the past 3 months
- Oxygen dependence of > 2 L/min continuously throughout the day at baseline
- Known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Pulmonary Function Damage Reduction, Standard of Care |
| Standard fractionationAlso: Cancer Radiotherapy, Radiation60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments | Radiation | Pulmonary Function Damage Reduction, Standard of Care |
| Stereotactic Body Radiation Therapy (SBRT)Also: SBRT, Cancer Radiotherapy, Radiation40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments | Radiation | Pulmonary Function Damage Reduction, Standard of Care |
| Four Dimensional Computed Tomographic Imaging (4DCT)Also: 4DCTSubjects undergo a total of 7 research-ordered four dimensional computed tomographic imaging (4DCT) scans: 1 at simulation, and 2 scans at each of the 3 post-radiation therapy time points (3, 6, and 12 months). 4DCT determines lung tissue elasticity and for standard of care radiation treatment planning. | Procedure or surgery | Pulmonary Function Damage Reduction, Standard of Care |
Primary outcome
Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT
Time frame: 3 months post RT
The primary endpoint of this study will be the ratio of the tissue elasticity map following RT to the elasticity map before RT (i.e., the Jacobian ratio of (post RT /pre RT)) calculated from 4DCT at 3 months post-RT. Based on the randomness of our measurement technique, diminished expansion (i.e. substantial change) is defined as a Jacobian ratio <0.94 (i.e., less than 94% of the pre-RT value).
9 secondary outcomes
Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)
Time frame: During therapy to 12 months post-RT
Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)
Time frame: During therapy to 12 months post-RT
Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)
Time frame: During therapy to 12 months post-RT
Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)
Time frame: During therapy to 12 months post-RT
Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Percent Change)
Time frame: During therapy to 12 months post-RT
Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Ratio)
Time frame: During therapy to 12 months post-RT
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Time frame: Pre-RT up to 12 months post-RT
Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves
Time frame: Up to 12 months post-RT
Variation of the Tissue Elasticity Calculated Between Scan 1 and Scan 2 at Each Time Point Will be Quantified and Compared to Longitudinal Changes in Tissue Elasticity
Time frame: Up to 12 months post-RT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38387810Baschnagel AM, Flakus MJ, Wallat EM, Wuschner AE, Chappell RJ, Bayliss RA, Kimple RJ, Christensen GE, Reinhardt JM, Bassetti MF, Bayouth JE. A Phase 2 Randomized Clinical Trial Evaluating 4-Dimensional Computed Tomography Ventilation-Based Functional Lung Avoidance Radiation Therapy for Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1393-1402. doi: 10.1016/j.ijrobp.2024.02.019. Epub 2024 Feb 20.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carri K Glide-Hurst, PhD, DABR, FAAPM principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Standard fractionation and Stereotactic Body Radiation Therapy (SBRT) in people with Non-Small Cell Lung Cancer, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT (time frame: 3 months post RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02843568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.