Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07432802
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07432802
Study Brief:
Protocol Section:
NCT07432802