[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623031":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":48,"interventions":65,"overallOfficials":41,"centralContacts":80,"locations":86,"responsibleParty":104,"collaborators":41,"id":107,"slug":41,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":41,"enrollmentInfo":116,"targetDuration":41,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":89,"whyStopped":41,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Lithuanian University of Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Local Tumor Control Rate Assessed by Endoscopy and Imaging","Proportion of participants without local tumor recurrence, assessed by laryngoscopic examination and radiological imaging.","At 2 years after completion of treatment; At 5 years after completion of treatment",[14,18,21,24,28,31,34,37],{"measure":15,"description":16,"timeFrame":17},"Laryngectomy-Free Survival (LFS)","Time from randomization to total laryngectomy or death from any cause, whichever occurs first.","Up to 2 years after randomization; Up to 5 years after randomization",{"measure":19,"description":20,"timeFrame":17},"Progression-Free Survival (PFS)","Time from randomization to disease progression (local, regional, or distant) or death from any cause, whichever occurs first.",{"measure":22,"description":23,"timeFrame":17},"Overall Survival (OS)","Time from randomization to death from any cause.",{"measure":25,"description":26,"timeFrame":27},"Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES)","Objective voice parameters derived from acoustic signal analysis using the lingWAVES system.","Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment",{"measure":29,"description":30,"timeFrame":27},"Patient-Reported Voice Outcome Assessed by Voice Screen Application","Patient-reported voice outcome assessed using the Voice Screen mobile application.",{"measure":32,"description":33,"timeFrame":27},"Swallowing Function Score Assessed by Anderson Dysphagia Inventory","Swallowing function assessed using the Anderson Dysphagia Inventory questionnaire (total score).",{"measure":35,"description":36,"timeFrame":27},"Health-Related Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35","Health-related quality of life assessed using the EORTC QLQ-C30 and QLQ-H\\&N35 questionnaires (global health status and domain scores).",{"measure":38,"description":39,"timeFrame":40},"Quantitative Radiomic and Dosiomic Feature Values and Their Statistical Associations With Clinical Outcomes","Quantitative radiomic feature values extracted from baseline and follow-up imaging (CT, MRI, PET\u002FCT) and quantitative dosiomic feature values derived from radiotherapy treatment plans. Associations with clinical outcomes (local tumor control, progression-free survival, overall survival) will be summarized using correlation coefficients and hazard ratios.","From baseline imaging through 5 years after completion of treatment",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE",[49,55,60],{"label":50,"type":51,"description":52,"interventionNames":53},"Arm A: Transoral CO₂ Laser Microsurgery (TLM)","ACTIVE_COMPARATOR","Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer.",[54],"Procedure: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization)",{"label":56,"type":51,"description":57,"interventionNames":58},"Arm B: Volumetric Modulated Arc Therapy (VMAT)","Participants receive definitive external beam radiotherapy using volumetric modulated arc therapy.",[59],"Radiation: VMAT radiotherapy",{"label":61,"type":51,"description":62,"interventionNames":63},"Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR)","Participants receive definitive MRI-guided stereotactic ablative radiotherapy.",[64],"Radiation: MRI-SABR",[66,71,76],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":41},"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).",[50],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":41},"RADIATION","VMAT radiotherapy","Accelerated fractionation schedule: T1N0 - 63 Gy\u002F28 fractions; T2N0 - 65.25 Gy\u002F29 fractions; delivered using Eclipse planning system.",[56],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":41},"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.",[61],[81],{"name":82,"role":83,"phone":84,"phoneExt":41,"email":85},"Viktoras Rudzianskas","CONTACT","+37068745515","viktoras.rudzianskas@kaunoklinikos.lt",[87],{"facility":88,"status":89,"city":90,"state":41,"zip":41,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Lithuanian University of Health Sciences Kaunas Clinics","RECRUITING","Kaunas","Lithuania","LT",{"type":94,"coordinates":95},"Point",[96,97],23.90909,54.90156,{"lat":97,"lon":96},[100],{"name":101,"role":83,"phone":102,"phoneExt":41,"email":103},"Vita Simonyte-Verbickiene","+37067140693","vita.simonyte-verbickiene@kaunoklinikos.lt",{"type":105,"investigatorFullName":82,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Principal investigator, Associate professor","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":117,"type":118},105,"ESTIMATED","INTERVENTIONAL",[121],"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.",[124,125],"Laryngeal Neoplasm","Glottic Carcinoma",[127,128,129,77,130,131,132],"Early-stage glottic laryngeal cancer","transoral laser microsurgery","VMAT","stereotactic radiotherapy","radiomics","dosiomics","2026-01-29",{"date":135,"type":136},"2026-02-05","ACTUAL",{"date":138,"type":136},"2024-09-01",{"date":140,"type":118},"2034-03",{"name":82,"class":6},1]