Improving Pulmonary Function Following Radiation Therapy

NCT02843568 | Completed Results DMC FDA Device

• 7 other identifiers: UW16037NCI-2016-010852016-0610A539933SMPH\VOLUNTEER STAFF\HUM ONCOLProtocol Version 6/9/2022R01CA166703
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved

  During therapy to 12 months post-RT

• Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved

  During therapy to 12 months post-RT

• Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs

  During therapy to 12 months post-RT

• Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves

  Up to 12 months post-RT

• Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)

  Pre-RT up to 12 months post-RT

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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; Radiation: Standard fractionation; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)

Pulmonary Function Damage Reduction

EXPERIMENTAL

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; Radiation: Standard fractionation; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Pulmonary Function Damage Reduction; Standard of Care

Standard fractionation RADIATION

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

Also known as: Cancer Radiotherapy, Radiation

Pulmonary Function Damage Reduction; Standard of Care

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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

Also known as: SBRT, Cancer Radiotherapy, Radiation

Pulmonary Function Damage Reduction; Standard of Care

Four Dimensional Computed Tomographic Imaging (4DCT) 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.

Also known as: 4DCT

Pulmonary Function Damage Reduction; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UW Johnson Creek

Johnson Creek, Wisconsin, 53038, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 38387810 RESULT

Related Links

• UW Carbone Cancer Center Home Page

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiation; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Cancer Connect
• Organization: University of Wisconsin Carbone Cancer Center

clinicaltrials@cancer.wisc.edu

800-622-8922

Study Officials

• Carri K Glide-Hurst, PhD, DABR, FAAPM

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 26, 2016
• Study Start: August 17, 2016
• Primary Completion: October 28, 2022
• Study Completion: August 16, 2023
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Locations

US (2)