Lung cancer showdown: surgery vs. radiation in High-Risk patients
NCT ID NCT07432802
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two treatments for high-risk patients with early-stage non-small cell lung cancer: minimally invasive surgery (wedge resection) and stereotactic body radiation therapy (SBRT). The goal is to see which approach leads to longer disease-free survival and better quality of life. The trial will enroll 182 participants across Denmark and follow them for up to 5 years.
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) or minimally invasive wedge resection surgery
- What this could lead to
- If this trial succeeds, it could provide clear evidence on whether radiation or surgery is better for controlling early-stage lung cancer in high-risk patients, helping doctors make more informed treatment decisions.
- What could go wrong
- This trial is not yet recruiting and has a relatively small size (182 participants). Results may not apply to all patients, and both treatments carry risks like complications from surgery or side effects from radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 182 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- 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: * Age ≥ 18 years * Biopsy-proven NSCLC * Diagnostic codes: DC34, DC 34.1, DC 34.2, DC 34.3 or DC 34.9 * Clinical stage I NSCLC according to the 9th edition of TNM * Performed diagnostic PET-CT and supplementary invasive procedures for staging purposes in accordance with the Danish national reference program for the staging and treatment of lung cancer (30) * 9th edition TNM staging: cT1aN0M0, cT1b-cN0M0, cT1cN0M0 and cT2aN0M0 (clinical stage I) * Tumor is localized in the outer third of the lung and considered technically resectable by SWR, as well as treatable with peripheral SBRT when assessed during MDT conference * Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0-2. * Preoperative pulmonary function test according to national guidelines performed within 6 weeks before the MDT conference * Patient fulfills the "high-risk patient" criteria outlined: A high-risk patient is a patient that fulfills at minimum one of the main-risk criteria and/or two of the secondary criteria: Main criteria: * FEV-1 ≤ 50% and/or * DLCO ≤ 50% Secondary criteria: * Age ≥ 80 * FEV-1 = 51-60% and/or DLCO = 51-60% * Known pulmonary hypertension with PAP ≥40 mm Hg diagnosed \< 6 months before inclusion * Known LVEF ≤ 40% diagnosed \< 6 months before inclusion Exclusion Criteria: * Declared terminally ill or life expectancy shorter than one year. * Multifocal disease * PS ≥ 3 * Centrally located tumors not eligible to SBRT * Previous ipsilateral lung surgery * Pregnancy or breastfeeding. * Inability to understand oral and written informed consent * Intravenous substance abuse or severe alcohol abuse (\> 25 units per week) * Not amendable for surgery in general anesthetic * Previous radiotherapy to the thorax, which may limit the feasibility or increase the risk of stereotactic reirradiation due to cumulative dose constraints and potential toxicity * Diagnosed with Interstitial lung disease (ILD)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aalborg University Hospital
Aalborg, Aalborg, Denmark
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Aarhus University Hospital
Aarhus N, 8200, Denmark
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Odense University Hospital
Odense, 5000, Denmark
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Rigshospitalet
Copenhagen, Copenhagen, 2100, Denmark
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Other studies related to the condition(s) this trial covers.
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- Can radiation spare the brain while fighting cancer in the spinal fluid?