Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Pulmonary Function Following Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843568
Recruitment Status : Suspended (Administrative suspension at the request of the Director, Office of Industry Engagement)
First Posted : July 26, 2016
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Other: Laboratory Biomarker Analysis Radiation: Standard fractionation Radiation: Stereotactic Body Radiation Therapy (SBRT) Procedure: Four Dimensional Computed Tomographic Imaging (4DCT) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Pulmonary Function Following Radiation Therapy
Actual Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Other: Laboratory Biomarker Analysis
Correlative studies

Radiation: Standard fractionation
60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Other Names:
  • Cancer Radiotherapy
  • Radiation

Radiation: Stereotactic Body Radiation Therapy (SBRT)
40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Other Names:
  • SBRT
  • Cancer Radiotherapy
  • Radiation

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.
Other Name: 4DCT

Experimental: 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.
Other: Laboratory Biomarker Analysis
Correlative studies

Radiation: Standard fractionation
60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Other Names:
  • Cancer Radiotherapy
  • Radiation

Radiation: Stereotactic Body Radiation Therapy (SBRT)
40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Other Names:
  • SBRT
  • Cancer Radiotherapy
  • Radiation

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.
Other Name: 4DCT




Primary Outcome Measures :
  1. Pulmonary function, based on changes in tissue elasticity measured from 4DCT [ Time Frame: 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 :
  1. Temporal changes in reduced elasticity, Jacobian ratio [ Time Frame: During therapy to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.

  2. Temporal changes in increased elasticity determined by the volume of lung where expansion is improved [ Time Frame: During therapy to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.

  3. Temporal changes in fraction of expanding lung determined by the volume of lung where "meaningful" expansion occurs [ Time Frame: During therapy to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.

  4. Validation in consistency of tissue elasticity changes measured with values predicted based on existing radiation dose response curves [ Time Frame: Up to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.

  5. Changes in PFTs [ Time Frame: Pre-RT up to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.

  6. Change in level of plasma TGF-beta1 measured by molecular specific enzyme linked immune sandwich assay [ Time Frame: Baseline up to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.

  7. Change in level of plasma cytokines measured by LINCOplex (microsphere-based sandwich immunoassay) [ Time Frame: Baseline up to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.

  8. 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 [ Time Frame: Up to 12 months post-RT ]
    All statistical tests will be two-sided and assessed for significance at the 5% level.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843568


Locations
Layout table for location information
United States, Wisconsin
UW Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: John Bayouth University of Wisconsin, Madison
Additional Information:
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02843568    
Other Study ID Numbers: UW16037
NCI-2016-01085 ( Registry Identifier: NCI Trial ID )
2016-0610 ( Other Identifier: Institutional Review Board )
A539933 ( Other Identifier: UW Madison )
SMPH\VOLUNTEER STAFF\HUM ONCOL ( Other Identifier: UW Madison )
Protocol Version 12/4/2019 ( Other Identifier: UW Madison )
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases