A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer

NCT05138900•Roswell Park Cancer Institute

Summary

The purpose of this study is to determine if a single treatment of targeted radiation (called SBRT or Stereotactic Body Radiation Therapy) can be as safe and effective as multiple doses of radiation in patients with central non-small cell lung cancer

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have an ECOG Performance Status of ≤ 2. Refer to Appendix A.
•Have histologically proven diagnosis of non-small cell lung cancer (NSCLC).
•Stage cT1-3N0M0 with tumor size \< 6 cm.

Exclusion Criteria

•Tumors located within 2 cm in all directions of any mediastinal critical structures, including the bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve, as defined by the International Association for the Study of Lung Cancer (IASLC) (27).
•Participant is considered to be either medically or surgically inoperable by physicians, or participant declines surgery.
•Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry.
•Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
•Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
•Contraindication to stereotactic body radiation therapy (SBRT) (including the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly)
•Prior radiation to the volume of lung or mediastinum currently involved by tumor
•Plan for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiation, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol, except at disease progression
•Received an investigational agent within 30 days prior to enrollment
•Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
+5 more criteria

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Key Dates

Start Date

December 16, 2021

Primary Completion Date

March 9, 2028

Completion Date

March 9, 2028

Last Updated

April 24, 2025

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

SBRT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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