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Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two treatment options for high‑risk patients with stage I NSCLC: sublobar wedge resection with lymph node sampling versus stereotactic body radiotherapy (SBRT). Eligible participants are adults with biopsy‑confirmed, clinical stage I NSCLC who are considered high‑risk but technically resectable or treatable with SBRT. The study aims to reduce selection bias by random assignment to either surgical or radiotherapy treatment and to compare outcomes such as overall survival and disease control. The trial is conducted across multiple Danish institutions, led by Aarhus University Hospital, with collaboration from Odense, Aalborg, and Copenhagen university hospitals.

Why it matters

Who can join: the full rules

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)

Where it's running

• Rigshospitalet
  Copenhagen, Copenhagen, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus N, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Thomas D Christensen, MD, DMSc, PhD. — Department of Cardiothoracic Surgery & Department of Clinical Medicine. Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N. DK-Denmark
• Study coordinator: Thomas D Christensen, MD, DMSc, PhD.
• Email: tdc@clin.au.dk
• Phone: 29418528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.