Improving Pulmonary Function Following Radiation Therapy

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Improving Pulmonary Function Following Radiation Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02843568
• Other study ID #: UW16037
• Secondary ID: NCI-2016-0108520
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 17, 2016
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 2023
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Radiation:
• Standard fractionation
60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
• Stereotactic Body Radiation Therapy (SBRT)
40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments

Procedure:
• Four Dimensional Computed Tomographic Imaging (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.

Locations

Country	Name	City	State
United States	UW Johnson Creek	Johnson Creek	Wisconsin
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 months post RT
Secondary	Temporal changes in reduced elasticity, Jacobian ratio	All statistical tests will be two-sided and assessed for significance at the 5% level.	During therapy to 12 months post-RT
Secondary	Temporal changes in increased elasticity determined by the volume of lung where expansion is improved	All statistical tests will be two-sided and assessed for significance at the 5% level.	During therapy to 12 months post-RT
Secondary	Temporal changes in fraction of expanding lung determined by the volume of lung where "meaningful" expansion occurs	All statistical tests will be two-sided and assessed for significance at the 5% level.	During therapy to 12 months post-RT
Secondary	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.	Up to 12 months post-RT
Secondary	Changes in PFTs	All statistical tests will be two-sided and assessed for significance at the 5% level.	Pre-RT up to 12 months post-RT
Secondary	Change in level of plasma TGF-beta1 measured by molecular specific enzyme linked immune sandwich assay	All statistical tests will be two-sided and assessed for significance at the 5% level.	Baseline up to 12 months post-RT
Secondary	Change in level of plasma cytokines measured by LINCOplex (microsphere-based sandwich immunoassay)	All statistical tests will be two-sided and assessed for significance at the 5% level.	Baseline up to 12 months post-RT
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	All statistical tests will be two-sided and assessed for significance at the 5% level.	Up to 12 months post-RT

External Links

•   UW Carbone Cancer Center Home Page