Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:19 AM
Study NCT ID:
NCT07432802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized 1:1 to either:\n\n* Surgery - minimal invasive SWR and lymph node sampling\n* SBRT Block restricted randomization with varying block sizes will be used to ensure an equal number of patients in both groups. The randomization will include stratification for treatment centers (Copenhagen University Hospital, Aarhus University Hospital, Odense University Hospital (including Vejle Hospital) and Aalborg University Hospital).\n\nEligible patients who meet the inclusion criteria will be offered to participate in this research project. Information is given to the patient by the responsible pulmonologist at the local department of pulmonology following the MDT in collaboration with the regional oncologists / thoracic surgeons. If the patient accepts inclusion, randomization is performed via a web-based randomization program, which is constructed in RedCap (Research Electronic Data Capture), (REDCap Consortium, Vanderbilt University Medical Center, Tennessee, USA) and housed'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2031-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 and 5 years', 'description': 'Overall survival after 3 and 5 years.'}, {'measure': 'Loco-regional recurrence rate', 'timeFrame': '2, 3 and 5 years', 'description': 'The 2-, 3- and 5-year loco-regional recurrence rate'}, {'measure': '5-year disease free survival', 'timeFrame': '5 years', 'description': 'The 5-year disease free survival'}, {'measure': 'Re-admissions 1', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'Re-admissions following treatment, adverse reactions and complications ranked by Clavien-Dindo classification.\n\nGrade I-V.'}, {'measure': 'Re-admissions 2', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'Re-admissions following treatment, adverse reactions and complications ranked Comprehensive Complication Index (CCI).\n\nNummerical scale, values form 0 to100'}, {'measure': 'Re-admissions 3', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'Re-admissions following treatment, adverse reactions and complications ranked by Common Toxicity Criteria for Adverse Events (CTCAE) version 5.\n\nGrade I-V.'}, {'measure': 'Health-care related costs', 'timeFrame': '12 and 36 months', 'description': "Health-care related costs within 12 and 36 months following treatment (measured i Euro's)"}, {'measure': 'PRO data - other than quality of life 1', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'PRO data - other than quality of life (health condition, symptoms and functional level).\n\nEuropean Quality of Life - 5 Dimensions (EQ-5D-5L): assess symptom or quality of life issues on a nummerical scale ranging from 1-5 and on a visual analog well being score ranging from 0-100'}, {'measure': 'PRO data - other than quality of life 2', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'PRO data - other than quality of life (health condition, symptoms and functional level). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): assess symptom or quality of life issues on a nummerical scale ranging from 1-4'}, {'measure': 'PRO data - other than quality of life 3', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'PRO data - other than quality of life (health condition, symptoms and functional level). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 29 (EORTC QLQ-LC29): assess symptom or quality of life issues on a nummerical scale ranging from 1-4'}, {'measure': 'Lung function test', 'timeFrame': '12 months', 'description': 'Lung function test after 12 month (FEV1 in %, scale: 0-100)'}], 'primaryOutcomes': [{'measure': 'Disease free survival (DFS)', 'timeFrame': '3 years', 'description': '• DFS of patients treated with either surgery (SWR) or SBRT after 3 years'}], 'secondaryOutcomes': [{'measure': 'Life quality', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'Quality of life after 1, 3, 6, 12 and 36 months PROs are collected from all patients before initiation of treatment (baseline measurements). As soon as the patient is diagnosed with stage I NSCLC and included in the study, a questionnaire will be distributed electronically to the patient using RedCap. When the patient visits the outpatient clinic to receive information concerning the diagnosis and treatment, the doctor informs the patient about the importance of the questionnaire and (if needed) how to fill it out electronically.\n\nEuropean Quality of Life - 5 Dimensions (EQ-5D-5L): assess symptom or quality of life issues on a nummerical scale ranging from 1-5 and on a visual analog well being score ranging from 0-100'}, {'measure': 'Life quality', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'Quality of life after 1, 3, 6, 12 and 36 months PROs are collected from all patients before initiation of treatment (baseline measurements). As soon as the patient is diagnosed with stage I NSCLC and included in the study, a questionnaire will be distributed electronically to the patient using RedCap. When the patient visits the outpatient clinic to receive information concerning the diagnosis and treatment, the doctor informs the patient about the importance of the questionnaire and (if needed) how to fill it out electronically.\n\nThe European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): assess symptom or quality of life issues on a nummerical scale ranging from 1-4'}, {'measure': 'Life quality', 'timeFrame': '1, 3, 6, 12 and 36 months', 'description': 'Quality of life after 1, 3, 6, 12 and 36 months PROs are collected from all patients before initiation of treatment (baseline measurements). As soon as the patient is diagnosed with stage I NSCLC and included in the study, a questionnaire will be distributed electronically to the patient using RedCap. When the patient visits the outpatient clinic to receive information concerning the diagnosis and treatment, the doctor informs the patient about the importance of the questionnaire and (if needed) how to fill it out electronically.\n\nThe European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 29 (EORTC QLQ-LC29): assess symptom or quality of life issues on a nummerical scale ranging from 1-4'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'surgery', 'Stereotactic radiotherapy treatment', 'randomized'], 'conditions': ['Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'In low-risk patients with stage I non-small cell lung cancer (NSCLC) surgical treatment with an anatomical resection is currently the standard of care.\n\nFor medically inoperable patients with stage I NSCLC, radiation therapy is currently the standard treatment. The latest generation of radiation therapy modalities is Stereotactic Body Radiation Therapy (SBRT).\n\nIn high-risk patients, minimal invasive surgery in terms of sublobar resection (wedge resection) with lymph node sampling is currently the recommended treatment approach for these patients, even though the evidence is limited. Additionally, SBRT is an alternative treatment option but the use in these patients is also based on weak evidence. So, it is highly warranted to compare these two treatment options in this group of patients in a randomized, controlled trial where selection bias can be eliminated. It is the specific aim of this study to provide such a trial allowing an evidence-based approach when deciding between surgery and SBRT as treatment for NSCLC in high-risk patients.\n\nThe STRADOS study (STereotactic RADiotherapy Or Surgery) is an open randomized, controlled national multicenter study in which high-risk patients with stage I non-small-cell lung cancer (NSCLC) are randomized to receive either surgical treatment with minimal invasive wedge resection with lymph node sampling, or SBRT.\n\nThe overall purpose of the study is to investigate the disease-free survival (DFS) after surgical treatment when compared to SBRT. The primary endpoint is DFS after 3 years. Secondary endpoint is quality of life after 1, 3, 6, 12 and 36 months. Tertiary endpoints are overall survival (OS) after 3 and 5 years; DFS after 5 years; re-admission adverse events and complications after 1, 3, 6, 12 and 36 months; health-care related costs within 12 and 36 months; PRO data - other than quality of life (QoL) (health condition, symptoms and functional level) after 1, 3, 6, 12 and 36 months and lung function test after 12 month.', 'detailedDescription': 'BACKGROUND:\n\nLung cancer is the most frequently diagnosed cancer type worldwide with approximately 2.5 million new cases and 1.8 million deaths annually, making it a leading cause of cancer-related mortality. The incidence of early-stage lung cancer is increasing likely due factors such as incidental findings, screening, increased awareness and the introduction of cancer packages.\n\nIn low-risk patients with stage I non-small cell lung cancer (NSCLC) surgical treatment with an anatomical resection is currently the standard of care.\n\nFor medically inoperable patients with stage I NSCLC, radiation therapy is currently the standard treatment. The latest generation of radiation therapy modalities is Stereotactic Body Radiation Therapy (SBRT).\n\nIn high-risk patients\' minimal invasive surgery with sublobar resection known as surgical wedge resection (SWR) with lymph node sampling is currently the recommended treatment approach for these patients but based on weak evidence.\n\nEXISTING KNOWLEDGE:\n\nSBRT has been reported to achieve 3-year overall survival (OS) rates ranging from 35 % - 65 %. There are several different possible reasons for the variability in outcome is multifactorial e.g., inclusion criteria\'s, co-morbidity and risk factors of patients.\n\nExisting non-randomized trials comparing SBRT to SWR indicate that SWR may confer a survival advantage in terms of higher OS and DFS.\n\nSWR has a lower risk of local recurrence, locoregional recurrence and regional recurrence and no lymph staging is performed in SBRT. The latter may lead to potential understaging and hence impact the indication for adjuvant therapy. However, it is extremely difficult to draw any firm conclusions due to selections bias of the conducted trials. In most studies SBRT patients have more risk factors than SWR patients, and selection bias is evident despite using advanced statistical method in terms of e.g. propensity matching.\n\nThe published systematic reviews and meta-analysis concluded that based on the non-randomized studies the outcome after SWR is probably better than after SBRT, but they all called for randomized, controlled trials. Two randomized, controlled trials have been initiated but both terminated before inclusion of the number of planned patients were reached due to slow recruiting. In the two trials, merely 58 patients were included, and analysis indicated better outcome in the SBRT group.\n\nIn terms of quality of life, Wisnivesky et al found in a non-randomized study from 2024 that SBRT provided a better quality of life immediately after treatment compared with SWR. However, both treatment groups reported similar quality of life at later time points, with a return to baseline quality of life suggesting that SWR and SBRT have a similar impact on the quality of life.\n\nThis has been confirmed by others, but never tested in a randomized setting, which is necessary in order to draw any firm conclusions.\n\nONGOING TRIALS:\n\nIn Clinicaltrials.gov three studies of interest are registered. In the POSTILV study (NCT01753414) (https://clinicaltrials.gov/study/NCT01753414?term=NCT01753414\\&rank=1) it is planned to investigate anatomical resections (segmentectomy and lobectomy) with SBRT in low-risk patients. This is also the case in the VALOR study (NCT02984761) (https://clinicaltrials.gov/study/NCT02984761?term=NCT02984761\\&rank=1) Accordingly, these two studies differ significantly from ours as these studies include low risk patients.\n\nThe STABLE-MATE study (NCT02468024) (https://clinicaltrials.gov/expert-search?term=NCT02468024) is actively recruiting. The study compares SWR to SBRT in high-risk patients with 3-year OS as primary outcome. The study is a multi-center study (48 sites) initiated in USA and predominantly recruiting patients from USA sites.\n\nInformed consent in the STABLE-MATE study will be obtained after patients are made aware of the randomized assignment, which entails attrition bias, i.e. patients may prefer SBRT and will refuse participation when randomized to surgery. In addition, secondary endpoints are merely progression free survival and radiation toxicity.\n\nThe STRADOS trial will include e.g. quality of life and health care cost, and it is a national trial including all relevant sites in Denmark.\n\nDespite the differences in the STABLE-MATE study and our study, the results are very likely to complement each other.\n\nNOVELTY:\n\nThis project will address a critical gap in the treatment of lung cancer of how to best to treat this relatively large group of high-risk patients with lung cancer. It will have both national and international impact, especially because of the randomized design and being a national study including all relevant departments and hence including all applicable patients in Denmark\n\nPURPOSE:\n\nThe overall purpose of this randomized, controlled trial is to investigate the 3-year DFS among high-risk patients with stage I NSCLC comparing SWR including lymph node sampling with SBRT (intervention).\n\nACRONYM:\n\nSTRADOS: STereotactic RADiotherapy Or Surgery\n\nMETHODS:\n\nIn the context of this study, a high-risk patient is defined as a patient that fulfills at minimum one of the main-risk criteria and/or two of the secondary criteria:\n\nMain criteria:\n\n* FEV-1 ≤ 50% and/or\n* DLCO ≤ 50%\n\nSecondary criteria:\n\n* Age ≥ 80\n* FEV-1 = 51-60% and/or DLCO = 51-60%\n* Known pulmonary hypertension with PAP ≥40 mm Hg diagnosed \\< 6 months before inclusion\n* Known LVEF ≤ 40% diagnosed \\< 6 months before inclusion\n\nPatients:\n\nInclusion criteria:\n\n* Patient fulfills the "high-risk patient" criteria outlined above\n* Age ≥ 18 years\n* Biopsy-proven NSCLC\n* Diagnostic codes: DC34, DC 34.1, DC 34.2, DC 34.3 or DC 34.9\n* Clinical stage I NSCLC according to the 9th edition of TNM (24) (cT1aN0M0, cT1b-cN0M0, cT1cN0M0 and cT2aN0M0)\n* 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\n* 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\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0-2.\n* Preoperative pulmonary function test according to national guidelines performed within 6 weeks before the MDT conference\n\nExclusion criteria:\n\n* Declared terminally ill or life expectancy shorter than one year.\n* Multifocal disease\n* PS ≥ 3\n* Centrally located tumors not eligible to SBRT\n* Previous ipsilateral lung surgery\n* Pregnancy or breastfeeding.\n* Inability to understand oral and written informed consent\n* Intravenous substance abuse or severe alcohol abuse (\\> 25 units per week)\n* Not amendable for surgery in general anesthetic\n* 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\n* Diagnosed with Interstitial lung disease (ILD)\n\nDesign:\n\n* Randomized, controlled study\n* Not blinded (open label)\n* National multicenter study including all thoracic surgical departments and relevant departments of oncology and pulmonology in Denmark\n* Endpoint are measured with the date of randomization as index\n\nPre-randomization investigations:\n\nStandard assessment according to the Danish national reference program for the assessment and treatment of lung cancer.\n\nSample size and power calculation:\n\nThe sample size calculation is based on the primary endpoint: 3-year DFS. The standard/control treatment is SWR, and the comparator/intervention is SBRT, and it set to be 70% and 50%, respectively.\n\nThe sample size is calculated with the 2-sided significance level of 0.05 and 80% statistical power, and hence 182 patients\' needs to be included (91 patients in each of the two groups), and with an expected dropout of approximately 10%, a total of 200 patients will be included.\n\nData analyses:\n\nData extraction is done from RedCap database. Before data analysis a statistical analysis plan will be presented. Data analysis is performed using STATA 18 (StataCorp LLC, Texas, USA).\n\nEndpoints for the individual group will be described with median and percentile, as we assume that data are not normally distributed.\n\nWe will use the ANOVA test to analyze repeated measurements (e.g. PROs) with treatment and time as systematic effects and patient as a random effect. The Χ2 test will be used when comparing the two treatments. All data are analyzed according to the intention to treat (ITT) principle, but a per protocol analysis will also be performed.\n\nData management:\n\nAll data are entered in a Case Report Form in RedCap (Research Electronic Data Capture - REDCap Consortium, Vanderbilt University Medical Center, Tennessee, USA). The Danish Data Inspectorate\'s guidelines are followed when handling, processing, and archiving collected data. All personally identifiable data are deleted at the end of the study.\n\nAll collected data are stored at the at Aarhus University. Data collection media are REDCap and electronic patient records.\n\nEthical considerations and inclusion of patients:\n\nThere is currently no evidence nor evidence-based consensus on which of the treatments investigated in this study is best (minimal invasive SWR or SBRT).\n\nThe individual patient will not benefit immediately from participating in this study, and the results of the study will only benefit future patients.\n\nThe procedure inclusion of patients and obtaining informed consent above ensures that the individual patient has the possibility to use or abstain from the usual 24 hours to consider study participation. From an ethical perspective the latter is important since some patients will wish to prioritize both study participation and at the same time not want a delay in time for referral though this is typically 24 hours. In the study population, a 24-hour delay in referral for definite treatment will not influence the outcome of the treatment or at a long term for the patient (e.g., mortality, and morbidity).\n\n1. Whether the patient meets the inclusion criteria and should be offered participation is decided and recorded at the MDT conference.\n2. Eligible patients possibly interested in study participation will receive both written and oral information about the study. When the pulmonologist informs the patient about the MDT results, the STRADOS project and possibility of participation in the study is presented. In current clinical practice, the result of the MDT is given to the patient in an outpatient clinic setting, using video consultation, or telephone. If the patient does not wish to participate, he/she will be referred to surgery as this is currently considered standard of practice. If the patient does not want operation, further referral will depend on patient preferences and current clinical practice guidelines for alternative treatment options incl. SBRT\n3. The patient is allowed 24 hours to consider whether they want to participate in the study.\n\nRisk:\n\nThe risks of surgical resection are predominantly bleeding, conversion to open surgery (thoracotomy), cardiac arrhythmias, postoperative air leakage from the lung, dyspnea, pain (both acute and chronic), and redo-surgery. The risks of SBRT are mainly pain, rash, rib fracture and radiation-induced pneumonitis. Overall, we believe that the knowledge gained from this study outweighs the disadvantages that patients might experience by participating.\n\nStudy approvals and registration:\n\nThe project is carried out in accordance with the Helsinki II Declaration and European regulations. The Scientific Ethics Committees for Denmark, the Data Protection Agency, is applied for permission to complete the program. Information concerning the patients is protected under the Personal Data Processing Act and the Health Act. The trial is registered at www.clinicaltrials.gov.\n\nORGANISATION:\n\nA steering committee is responsible for the design, conduct, analysis and reporting the results of the trial. The multidisciplinary steering committee includes Thomas Decker Christensen MD, PhD (thoracic surgery) (PI), Christian B. Laursen, MD, PhD (respiratory medicine) (Co-PI), Peter Licht MD, PhD (thoracic surgery), Rene Horsleben Petersen MD, PhD (thoracic surgery), Tine Schytte MD, PhD (oncology) Weronika Maria Szejniuk MD, PhD (oncology) and Asger Roer Pedersen MSc, PhD (statistical supervisor). A total of approximately 33 Danish and international health care professionals with a multi-disciplinary background (e.g., oncologist, thoracic surgeons, respiratory physicians and radio physics) has read, commented and accepted the protocol and the initiation of the study.\n\nInternational project collaborators and advisors:\n\nThoracic Surgery:\n\n* Professor Hiran C. Fernando. Inova Fairfax Hospital, Falls Church, Virginia, USA.\n* Professor Yaron Shargall, Chair at Division of Thoracic Surgery, McMaster University, Canada\n* Professor Babu Naidu. Department of Thoracic Surgery, Queen Elisabeth Hospital, Birmingham, UK.\n\nOncology:\n\n* Professor Robert Timmerman. Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, USA\n* Professor Matthias Guckenberger. Department of Radiation Oncology, University Hospital Zurich and University of Zurich.\n\nRespiratory Medicine:\n\n• Professor Najib N. Rahman. Nuffield Department of Medicine, Clinical Director, Oxford Respiratory Trials Unit, University of Oxford, UK\n\nImplementation:\n\nThis is a pragmatic, national, multicenter study conducted within a well-established national reference program for lung cancer diagnosis and treatment. Regardless of whether the results are positive or negative, they can be rapidly integrated into the national reference program, minimizing the time from clinical research to clinical implementation. At the end of the study a one-day seminary dedicated to ensuring an implementation strategy of study results into the national reference program is planned.\n\nClinical and national and international perspective:\n\nThis project will address a critical gap in the treatment of lung cancer of how to best to treat this relatively large group of patients with lung cancer. The results of the trial will impact evidence-based treatment both nationally and internationally.\n\nUltimately, the project aims to improve morbidity and reduce morbidity and improve quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Biopsy-proven NSCLC\n* Diagnostic codes: DC34, DC 34.1, DC 34.2, DC 34.3 or DC 34.9\n* Clinical stage I NSCLC according to the 9th edition of TNM\n* 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)\n* 9th edition TNM staging: cT1aN0M0, cT1b-cN0M0, cT1cN0M0 and cT2aN0M0 (clinical stage I)\n* 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\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0-2.\n* Preoperative pulmonary function test according to national guidelines performed within 6 weeks before the MDT conference\n* Patient fulfills the "high-risk patient" criteria outlined:\n\nA high-risk patient is a patient that fulfills at minimum one of the main-risk criteria and/or two of the secondary criteria:\n\nMain criteria:\n\n* FEV-1 ≤ 50% and/or\n* DLCO ≤ 50%\n\nSecondary criteria:\n\n* Age ≥ 80\n* FEV-1 = 51-60% and/or DLCO = 51-60%\n* Known pulmonary hypertension with PAP ≥40 mm Hg diagnosed \\< 6 months before inclusion\n* Known LVEF ≤ 40% diagnosed \\< 6 months before inclusion\n\nExclusion Criteria:\n\n* Declared terminally ill or life expectancy shorter than one year.\n* Multifocal disease\n* PS ≥ 3\n* Centrally located tumors not eligible to SBRT\n* Previous ipsilateral lung surgery\n* Pregnancy or breastfeeding.\n* Inability to understand oral and written informed consent\n* Intravenous substance abuse or severe alcohol abuse (\\> 25 units per week)\n* Not amendable for surgery in general anesthetic\n* 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\n* Diagnosed with Interstitial lung disease (ILD)'}, 'identificationModule': {'nctId': 'NCT07432802', 'acronym': 'STRADOS', 'briefTitle': 'Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer - a Randomized, Controlled Trial The STRADOS Trial', 'orgStudyIdInfo': {'id': '1-10-72-205-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical treatment', 'description': 'Patients who are randomized to have surgery undergo a SWR via a minimal approach (VATS or RATS) during general anesthesia. Pre- and postoperative care and treatment is offered in accordance with local department guidelines. The surgery must be performed or supervised by a specialist in thoracic surgery. The operation is performed with the patient in lateral recumbent position. The surgeon decides the number of ports (1-4), and local analgesic is applied at the incision sites and/or as a nerve block. Additional pain management is registered and performed according to the local practice at the individual department. At the end of surgery, a chest tube is inserted in pleura through one of the ports, and the tube is connected to suction at levels decided by the treating surgeon.\n\nPatients in which minimal surgery is converted to thoracotomy are included in an intention-to-treat analysis.', 'interventionNames': ['Procedure: Surgical intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Stereotactic Body Radiation Therapy (SBRT)', 'description': 'The SBRT planning technique is based on recommendations from the Advisory Committee on Radiation Oncology Practice (ACROP) guideline and the ICRU report 91: Prescribing, Recording and Reporting of Stereotactic Treatments with Small Photon Beams as implemented in the recommendations from the Radiotherapy Committee of Danish Oncology Lung Cancer Group. Planning should be guided by respiratory guided CT scans', 'interventionNames': ['Radiation: Stereotactic radiation therapy intervention']}], 'interventions': [{'name': 'Stereotactic radiation therapy intervention', 'type': 'RADIATION', 'description': 'The SBRT planning technique is based on recommendations from the Advisory Committee on Radiation Oncology Practice (ACROP) guideline and the ICRU report 91: Prescribing, Recording and Reporting of Stereotactic Treatments with Small Photon Beams as implemented in the recommendations from the Radiotherapy Committee of Danish Oncology Lung Cancer Group. Planning should be guided by respiratory guided CT scans', 'armGroupLabels': ['Stereotactic Body Radiation Therapy (SBRT)']}, {'name': 'Surgical intervention', 'type': 'PROCEDURE', 'description': 'Patients who are randomized to have surgery undergo a SWR via a minimal approach (VATS or RATS) during general anesthesia. Pre- and postoperative care and treatment is offered in accordance with local department guidelines. The surgery must be performed or supervised by a specialist in thoracic surgery. The operation is performed with the patient in lateral recumbent position. The surgeon decides the number of ports (1-4), and local analgesic is applied at the incision sites and/or as a nerve block. Additional pain management is registered and performed according to the local practice at the individual department. At the end of surgery, a chest tube is inserted in pleura through one of the ports, and the tube is connected to suction at levels decided by the treating surgeon.\n\nPatients in which minimal surgery is converted to thoracotomy are included in an intention-to-treat analysis.', 'armGroupLabels': ['Surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'contacts': [{'name': 'Rene H Petersen, MD, PhD.', 'role': 'CONTACT', 'email': 'Rene.Horsleben.Petersen@regionh.dk', 'phone': '2649 4949', 'phoneExt': '+45'}, {'name': 'Rene H Petersen, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'Aalborg', 'city': 'Aalborg', 'country': 'Denmark', 'contacts': [{'name': 'Weronika M Szejniuk, MD, PhD.', 'role': 'CONTACT', 'email': 'wms@rn.dk', 'phone': '97661524', 'phoneExt': '+45'}, {'name': 'Weronika M Szejniuk, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'contacts': [{'name': 'Thomas Christensen, MD, DMSc, PhD.', 'role': 'CONTACT', 'email': 'tdc@clin.au.dk', 'phone': '29418528', 'phoneExt': '+45'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'contacts': [{'name': 'Christian B Lursen, MD, PhD.', 'role': 'CONTACT', 'email': 'Christian.B.Laursen@rsyd.dk', 'phone': '3023 1114', 'phoneExt': '+45'}, {'role': 'CONTACT', 'email': 'Christian.B.Laursen@rsyd.dk'}, {'name': 'Christian B. Laursen, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Peter B. Licht, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tine Schytte, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Thomas D Christensen, MD, DMSc, PhD.', 'role': 'CONTACT', 'email': 'tdc@clin.au.dk', 'phone': '29418528', 'phoneExt': '+45'}, {'name': 'Christian B Larsen, MD, PhD.', 'role': 'CONTACT', 'email': 'Christian.b.lauersen@rsyd.dk', 'phone': '3023 1114', 'phoneExt': '+45'}], 'overallOfficials': [{'name': 'Thomas D Christensen, MD, DMSc, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiothoracic Surgery & Department of Clinical Medicine. Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N. DK-Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '1 September 2026', 'ipdSharing': 'YES', 'accessCriteria': 'By contacting the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, {'name': 'Vejle Hospital', 'class': 'OTHER'}, {'name': 'Zealand University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, consultant, MD, DMSc, PhD', 'investigatorFullName': 'Thomas Decker Christensen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}