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Lung cancer showdown: surgery vs. radiation in High-Risk patients

NCT ID NCT07432802

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Aalborg University Hospital

    Aalborg, Aalborg, Denmark

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • Odense University Hospital

    Odense, 5000, Denmark

  • Rigshospitalet

    Copenhagen, Copenhagen, 2100, Denmark

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