Improving Pulmonary Function Following Radiation Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-17

Study Completion Date

2023-08-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

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.

Group Type ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Standard fractionation

Intervention Type RADIATION

60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type RADIATION

40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments

Four Dimensional Computed Tomographic Imaging (4DCT)

Intervention Type PROCEDURE

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.

Pulmonary Function Damage Reduction

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.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Standard fractionation

Intervention Type RADIATION

60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type RADIATION

40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments

Four Dimensional Computed Tomographic Imaging (4DCT)

Intervention Type PROCEDURE

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.

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Standard fractionation

60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments

Intervention Type RADIATION

Stereotactic Body Radiation Therapy (SBRT)

40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments

Intervention Type RADIATION

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.

Intervention Type PROCEDURE

Other Intervention Names

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Cancer Radiotherapy Radiation SBRT Cancer Radiotherapy Radiation 4DCT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No