[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623031":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":40,"locations":46,"responsibleParty":64,"collaborators":30,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":30,"enrollmentInfo":77,"targetDuration":30,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Lithuanian University of Health Sciences","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Transoral CO₂ Laser Microsurgery (TLM)","ACTIVE_COMPARATOR","Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer.",[13],"Procedure: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B: Volumetric Modulated Arc Therapy (VMAT)","Participants receive definitive external beam radiotherapy using volumetric modulated arc therapy.",[18],"Radiation: VMAT radiotherapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR)","Participants receive definitive MRI-guided stereotactic ablative radiotherapy.",[23],"Radiation: MRI-SABR",[25,31,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization)","Surgical removal of the tumor with at least 2 mm margins; intraoperative frozen section biopsies; short hospitalization (1-3 days).",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"RADIATION","VMAT radiotherapy","Accelerated fractionation schedule: T1N0 - 63 Gy\u002F28 fractions; T2N0 - 65.25 Gy\u002F29 fractions; delivered using Eclipse planning system.",[15],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"MRI-SABR","42.5 Gy total dose in 5 fractions, 2 fractions per week, planned with CT and MRI simulation and delivered with MRI-LINAC system.",[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Viktoras Rudzianskas","CONTACT","+37068745515","viktoras.rudzianskas@kaunoklinikos.lt",[47],{"facility":48,"status":49,"city":50,"state":30,"zip":30,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Lithuanian University of Health Sciences Kaunas Clinics","RECRUITING","Kaunas","Lithuania","LT",{"type":54,"coordinates":55},"Point",[56,57],23.90909,54.90156,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":62,"phoneExt":30,"email":63},"Vita Simonyte-Verbickiene","+37067140693","vita.simonyte-verbickiene@kaunoklinikos.lt",{"type":65,"investigatorFullName":42,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Principal investigator, Associate professor","100623031","precision-medicine-mri-guided-stereotactic-ablative-radiotherapy-mri-sabr-for-early-stage-glottic-laryngeal-cancer-100623031",false,"NCT07391345","Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer","A Prospective, Randomized, Three-Arm, Open-Label Clinical Trial Comparing Transoral CO₂ Laser Microsurgery, Volumetric Modulated Arc Therapy (VMAT), and MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) in the Treatment of Early-Stage Glottic Laryngeal Cancer","SMART - 1_1","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed squamous cell carcinoma of the glottic larynx, including verrucous carcinoma.\n* Stage T1-T2N0 (8th TNM edition).\n* ECOG performance status 0-2.\n* Able to understand Lithuanian and complete questionnaires.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* AJCC stage III-IV laryngeal cancer.\n* Prior radiotherapy for head and neck cancer.\n* Pregnancy or breastfeeding.\n* Contraindications for radiotherapy or inability to follow-up.\n* Presence of another active malignancy.\n* Uncontrolled intercurrent illness (e.g., active infection, symptomatic CHF, unstable angina, clinically significant arrhythmia) or any condition that would preclude radiotherapy or adequate follow-up per investigator judgment.","ALL","18 Years",{"count":78,"type":79},105,"ESTIMATED","INTERVENTIONAL",[82],"NA","This randomized phase III trial will compare the outcomes of three treatment modalities for early-stage glottic laryngeal cancer (T1-T2N0): transoral CO₂ laser microsurgery (TLM), volumetric modulated arc therapy (VMAT), and MRI-guided stereotactic ablative radiotherapy (MRI-SABR). The primary endpoint is local control (LC). Secondary endpoints include laryngectomy-free survival (LFS), progression-free survival (PFS). overall survival (OS), functional voice, swallowing and breathing outcomes, treatment-related complications, and the evaluation of radiomic and dosiomic biomarkers. Patients will be randomized in a 1:1:1 ratio. Total planned enrollment is 105.",[85,86],"Laryngeal Neoplasm","Glottic Carcinoma",[88,89,90,37,91,92,93],"Early-stage glottic laryngeal cancer","transoral laser microsurgery","VMAT","stereotactic radiotherapy","radiomics","dosiomics","2026-01-29",{"date":96,"type":97},"2026-02-05","ACTUAL",{"date":99,"type":97},"2024-09-01",{"date":101,"type":79},"2034-03",{"name":42,"class":6},1]