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Stereotactic Ablative Radiotherapy for Early-Stage Lung Cancer

This study is comparing two ways to give stereotactic ablative radiotherapy (SBRT) for early-stage non-small cell lung cancer. One method is standard SBRT, and the other is SBRT with "hot spots," which means the tumor gets a higher radiation dose. Researchers want to see if SBRT with hot spots is better at controlling the tumor, even if it might cause more side effects. You could be eligible if you are at least 18 years old, have early-stage non-small cell lung cancer confirmed by biopsy, and have a good performance status. The main goal is to see how long it takes for the cancer to return (local control) over two years.

Study design
This interventional study plans to enroll 200 participants. It compares two different ways of delivering radiation therapy.
What's involved
You would undergo blood sample collection, CT scans, lymph node sampling, PET scans, and receive SBRT radiation treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long it takes for the cancer to return for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07718672

Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~200 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyLymph Node BiopsyPositron Emission TomographyStereotactic Body Radiation TherapySurvey Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to progression (local control)
Measured over Up to 2 years

Conditions

Early Stage Lung Non-Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Mark Farrugia · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Mark Farrugia
[email protected]
716-845-1179
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation
Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled
Eligible for SABR
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

Exclusion

Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy
Mixed small cell and non-small cell lung cancer
History of allogeneic organ transplantation
History of primary immunodeficiency
Patients must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
Active autoimmune disease that has required systemic treatment in the last 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Known EGFR or ALK mutation
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
Pregnant or nursing female participant
Unwilling or unable to follow protocol requirements

What this trial measures

  • Time to progression (local control)Up to 2 years

    Defined as no failure within the radiotherapy planning target volume (PTV), based on the international consensus on assessing local failure after stereotactic ablative radiotherapy (SBRT) will be utilized. The 2-year local control rates will be summarized by treatment arms using 90% Clopper-Pearson confidence intervals. The local control rates between arms will be compared using one-sided Cochrane-Mantel-Haenszel test (alpha=0.1), stratified by performance status, surgery candidacy, and beta-blocker usage.