Lung cancer pilot: High-Dose radiation before surgery tested
NCT ID NCT03348748
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase pilot study looked at combining stereotactic body radiation therapy (SBRT) with surgery for patients with stage I-IIIA non-small cell lung cancer. SBRT delivers very high, precise radiation doses to the tumor while sparing healthy tissue. The study aimed to check safety and side effects, but it was terminated early with only 20 participants planned.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this approach could show that giving a precise, high-dose radiation before surgery is safe and may improve outcomes for lung cancer patients.
- What could go wrong
- This was a very early, small pilot study that was terminated, so results are limited. The combination may not prove safer or more effective than standard treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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20 people
The number who actually took part.
- Started
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Dec 2017
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa) * Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed * Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for \>3 years * Participant is able to undergo surgery (planned lobectomy or wedge resection) * Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment * Participant or legal representative 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 Criteria: * Contraindication to SBRT (this includes the inability to cooperate with any aspect of SBRT: such as the inability to lie still and breathe reproducibly) * Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor * Previous surgery for this lung or mediastinum tumor * Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression * Patients with active systemic, pulmonary, or pericardial infection * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the investigator?s opinion deems the participant ineligible * Received an investigational agent within 30 days prior to enrollment * Stage IIIb
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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