Who is eligible for clinical trial NCT05138900?

Participants must meet the protocol's inclusion criteria for Non Small Cell Lung Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05138900 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-29

A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer (NCT05138900)

🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Roswell Park Cancer Institute

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (11 items).

Location: Roswell Park Cancer Institute — Buffalo, New York

Age range: 18 Years

🧪 Interventions in This Study

SBRT (RADIATION)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.
Prior systemic therapy allowed but no systemic therapy 4-6 weeks prior to stereotactic body radiation therapy SBRT (see exclusion criteria), during SBRT, or 2 weeks after SBRT.
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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
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.
Pregnant or nursing female participants.
Unwilling or unable to follow protocol requirements.
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive SBRT

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Roswell Park Cancer Institute — Buffalo, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗