Clinical trial NCT02843568: Improving Pulmonary Function Following Radiation Therapy
Official title: Improving Pulmonary Function Following Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-26
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT
timeFrame: 3 months post RT
Secondary outcomes:
measure: Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved
timeFrame: During therapy to 12 months post-RT
measure: Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved
timeFrame: During therapy to 12 months post-RT
measure: Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs
timeFrame: During therapy to 12 months post-RT
measure: Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves
timeFrame: Up to 12 months post-RT
measure: Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
timeFrame: Pre-RT up to 12 months post-RT
measure: Change in Level of Plasma TGF-beta
timeFrame: Baseline up to 12 months post-RT
measure: Change in Level of Plasma Cytokines
timeFrame: Baseline up to 12 months post-RT
measure: 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
timeFrame: Up to 12 months post-RT
Other outcomes:
Locations:
city: Johnson Creek
country: United States
facility: UW Johnson Creek
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Carri K Glide-Hurst, PhD, DABR, FAAPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.