Not Yet RecruitingPhase 1NCT07852247
Official study title

SBRT for Ultra-Central NonSmall Cell Lung Cancer

Study summary

The goal of this clinical trial is to find out if Five-fraction CyberKnife stereotactic body radiation therapy (SBRT) with real-time Synchrony® motion tracking can treat ultra-central nonsmall cell lung cancer while reducing the amount of serious side effects from SBRT. Participants will * receive radiation treatment every other day over two weeks using a machine called the CyberKnife®, which uses a technology called Synchrony® motion management, which tracks your tumor in real time as it moves with your breathing. This allows the radiation beam to follow your tumor during treatment, helping to deliver the radiation more accurately to the tumor while reducing the dose to nearby healthy organs. * return for follow up visits after treatment at months 3, 6, 9, 12, 18, 24 and then every year for 5 years to be evaluated * complete questionnaires before and after treatment.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSBRT

The study team can explain what participation involves.

Who it may be forNonsmall Cell Lung Cancer Stage

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Georgetown University

Study sponsor

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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Georgetown University
Interventions being studied
Radiation: SBRT
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 1. Patients aged 18 or older. 2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 3. Patients with confirmed tumor location using advanced imaging to ensure accurate classification of ultra-central NSCLC. 4. Ability to undergo bronchoscopy and Endobronchial ultrasound (EBUS) with adequate fiducial placement 5. Histologically or cytologically confirmed clinical stage T1-T2 N0 M0 NSCLC (AJCC 9th edition), with maximum tumor diameter ≤5 cm. 6. Absence of overt radiological or bronchoscopy assessed gross endobronchial invasion, invasion of the trachea, esophagus, major blood vessels, or other mediastinal structures. 7. 4D-CT (computed tomography) scans will be required to evaluate tumor motion and verification at time of simulation: ○ Screening for ultra-central tumor deformation between inhalation and exhalation extremities will be performed via 4D-CT to avoid inappropriate margins for significant tumor motion or deformation. 8. Ultra-central tumors must include: o Gross Tumor Volume (GTV) or Planning Target Volume (PTV) located within 1 cm (centimeter) of the Proximal Bronchial Tree (PBT) and/or at least one of the following: (1) GTV or protocol PTV within 1 cm of the PBT; or (2) GTV within 5 mm of or abutting/overlapping the esophagus, heart/pericardium, aorta, pulmonary artery, or pulmonary vein. 9. Patients are eligible to receive SBRT:
  • Patients deemed suitable for SBRT based on multidisciplinary evaluation;
  • Medically inoperable, decline surgery or high surgical risk as determined by a thoracic surgeon or multidisciplinary tumor board;
  • No prior overlapping thoracic radiation exceeding dose constraints for critical structures;
  • Adequate pulmonary function to tolerate procedure;
  • A minimum of two gold fiducials will be placed in or adjacent to the tumor via bronchoscopy and will be tracked/evaluated by the treating radiation oncologist and/or physicist/dosimetrist to determine quality of fiducial placement for trial inclusion. 10. Patients are eligible to receive radiation therapy:
  • Candidate for CyberKnife radiosurgery using Synchrony motion management;
  • 4D-CT is required to evaluate tumor motion. Patients with \>1.5 cm excursion in any dimension will require a 5 mm PTV margin and remain eligible only if all mandatory Organs-at-risk (OAR) dosimetric and planning constraints can be met; otherwise, they are ineligible for protocol treatment.
  • OAR constraints will be prioritized over target coverage. Patients who cannot meet mandatory airway, esophagus, great vessel, heart, spinal cord, and lung constraints are not eligible for protocol treatment. 11. Female patients of childbearing potential must have a negative pregnancy test prior to treatment and agree to contraception during and for a defined period after treatment. 12. Patients who can comply with follow-up visits and treatment plans. 13. Patients who can provide written informed consent prior to study procedures.
Reasons someone may not be able to joinExclusion criteria

1. Patients with evidence of nodal involvement (N1-N3) or distant metastases (M1). 2. Patients with previous radiation therapy to the thorax that would result in overlap with the planned treatment field. 3. Patients with tumor-associated bronchial compression, defined as visible deformation or narrowing of the trachea, mainstem bronchus, or bronchus intermedius on diagnostic CT, simulation CT, or bronchoscopy. 4. Patients receiving concurrent chemotherapy, immunotherapy, or targeted therapy during SBRT. 5. Patients with active connective tissue disease (e.g., lupus, scleroderma, polymyositis, rheumatoid arthritis). 6. Patients with interstitial lung disease of any etiology. 7. Patients on Vascular Endothelial Growth Factor (VEGF) inhibitors. 8. Patients with tumor invasion of any major airways, esophagus, or major blood vessels. 9. Patients with evidence of endobronchial disease. 10. Patients who fail to place fiducial markers for Synchrony tracking. 11. Patients who require alternate fractionation scheduling. 12. Patients who are pregnant or are breastfeeding. 13. Patients who are unable to lie flat for the duration of treatment (approximately 45-60 minutes per fraction). 14. Patients with psychiatric illness or social situation that would limit compliance with study requirements. 15. Patients who are unable to or unwilling to give informed consent.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Lombardi Comprehensive Cancer Center, Georgetown University Medical CenterWashington D.C., District of Columbia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 1, 2026. Always confirm current availability with the study team.

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