N/A
N=122
Improving Pulmonary Function Following Radiation Therapy
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02843568 ↗Enrolled (actual)
122
Serious AEs
14.7%
Results posted
Oct 2024
Primary outcome: Primary: Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT — 1.09; 1.13 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboratory Biomarker Analysis (Other); Standard fractionation (Radiation); Stereotactic Body Radiation Therapy (SBRT) (Radiation); Four Dimensional Computed Tomographic Imaging (4DCT) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT |
1.09; 1.13 | — |
| SECONDARY Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved |
— | — |
| SECONDARY Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved |
— | — |
| SECONDARY Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs |
— | — |
| SECONDARY Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves |
— | — |
| SECONDARY Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs) |
-5; -3; -2; -2; -4; -4 | — |
| SECONDARY Change in Level of Plasma TGF-beta |
— | — |
| SECONDARY Change in Level of Plasma Cytokines |
— | — |
| SECONDARY 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 |
— | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02843568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.