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Radiation Therapy

Radiation Therapy for Non-Small Cell Lung Cancer

N/A
Waitlist Available
Led By John Bayouth
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post-rt
Awards & highlights

Study Summary

This trialaims to develop radiation plans to preserve healthy lung tissue near tumors using 4DCT scans to locate the tumor & healthy tissue.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post-rt
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-rt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pulmonary function, based on changes in tissue elasticity measured from 4DCT
Secondary outcome measures
Change in level of plasma TGF-beta1 measured by molecular specific enzyme linked immune sandwich assay
Change in level of plasma cytokines measured by LINCOplex (microsphere-based sandwich immunoassay)
Changes in PFTs
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pulmonary Function Damage ReductionExperimental Treatment4 Interventions
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 II: Standard of CareActive Control4 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,259 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,025 Total Patients Enrolled
John BayouthPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Standard fractionation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02843568 — N/A
Non-Small Cell Lung Cancer Research Study Groups: Standard of Care, Pulmonary Function Damage Reduction
Non-Small Cell Lung Cancer Clinical Trial 2023: Standard fractionation Highlights & Side Effects. Trial Name: NCT02843568 — N/A
Standard fractionation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02843568 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Improving Pulmonary Function Following Radiation Therapy
2016. "Improving Pulmonary Function Following Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02843568.
~15 spots leftby Apr 2025
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