Improving Pulmonary Function Following Radiation Therapy
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT02843568
- Lead Sponsor
- University of Wisconsin, Madison
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT 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).
- Secondary Outcome Measures
Name Time Method Change in Level of Plasma TGF-beta Baseline up to 12 months post-RT All statistical tests will be two-sided and assessed for significance at the 5% level.
Change in Level of Plasma Cytokines Baseline up to 12 months post-RT All statistical tests will be two-sided and assessed for significance at the 5% level.
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 Up to 12 months post-RT All statistical tests will be two-sided and assessed for significance at the 5% level.
Temporal Changes in Reduced Elasticity 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.
Temporal Changes in Increased Elasticity 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.
Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs During therapy to 12 months post-RT All statistical tests will be two-sided and assessed for significance at the 5% level.
Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves Up to 12 months post-RT All statistical tests will be two-sided and assessed for significance at the 5% level.
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs) Pre-RT up to 12 months post-RT 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.
Trial Locations
- Locations (2)
UW Johnson Creek
🇺🇸Johnson Creek, Wisconsin, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
UW Johnson Creek🇺🇸Johnson Creek, Wisconsin, United States