Improving Pulmonary Function Following Radiation Therapy

University of Wisconsin (UW)

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Treatments: Procedure: Four Dimensional Computed Tomographic Imaging (4DCT); Radiation: Stereotactic Body Radiation Therapy (SBRT); Other: Laboratory Biomarker Analysis; Radiation: Standard fractionation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02843568

UW16037

R01CA166703 (U.S. NIH Grant/Contract)

NCI-2016-01085 (Registry Identifier)

Protocol Version 6/9/2022 (Other Identifier)

2016-0610 (Other Identifier)

SMPH\VOLUNTEER STAFF\HUM ONCOL (Other Identifier)

A539933 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Radiation: Standard fractionation

Other: Laboratory Biomarker Analysis

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)

Pulmonary Function Damage Reduction

Experimental group

Description:

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.

Treatment:

Radiation: Standard fractionation

Other: Laboratory Biomarker Analysis

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)