Clinical trial · Interventional
Improving Pulmonary Function Following Radiation Therapy
NCT02843568CI-TRIAL-00116858completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Four Dimensional Computed Tomographic Imaging (4DCT) | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Standard fractionation | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Radiation: Standard fractionation
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
- Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)
- type
- EXPERIMENTAL
- label
- Pulmonary Function Damage Reduction
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTBaschnagel 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