[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634512":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":47,"studyPopulation":38,"armGroups":48,"interventions":61,"overallOfficials":38,"centralContacts":70,"locations":80,"responsibleParty":96,"collaborators":38,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":38,"enrollmentInfo":108,"targetDuration":38,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":82,"whyStopped":38,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"1-year rate of skeletal-related events (SREs)","Number of participants experiencing at least one skeletal-related event (pathological fracture, spinal cord compression, need for radiation to bone, need for surgery to bone, or tumor-related hypercalcemia) within 12 months after randomization.","From randomization to 12 months after randomization",[14,18,22,26,29,32,35],{"measure":15,"description":16,"timeFrame":17},"Incidence of adverse events","Adverse events assessed and graded according to CTCAE version 6.0","Up to 12 months after randomization",{"measure":19,"description":20,"timeFrame":21},"EORTC QLQ-C30 global health status score","EORTC QLQ-C30 global health status score at each assessment time point (range: 0-100; higher scores indicate better quality of life).","Baseline, 3 months, 6 months, and 12 months after randomization",{"measure":23,"description":24,"timeFrame":25},"EQ-5D-5L index score","EQ-5D-5L index score at each assessment time point (range typically from \\\u003C0 to 1; higher values indicate better health status).","Baseline and follow-up visits up to 12 months after randomization",{"measure":27,"description":28,"timeFrame":25},"Brief Pain Inventory (BPI) pain intensity score","Pain intensity score measured using the Brief Pain Inventory (scale 0-10; higher scores indicate worse pain).",{"measure":30,"description":31,"timeFrame":12},"Pain-free survival","Time from randomization to first occurrence of pain requiring opioid analgesics or death from any cause, whichever occurs first.",{"measure":33,"description":34,"timeFrame":12},"Overall survival","Time from randomization to death from any cause.",{"measure":36,"description":37,"timeFrame":12},"Healthcare resource utilization","Number and duration of hospitalizations, number of outpatient visits, and associated healthcare costs during the study period.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Participants are randomized in a 1:1 ratio to one of two parallel groups:\n\n1. standard of care systemic therapy or observation, or\n2. prophylactic external-beam radiotherapy in addition to standard of care systemic therapy or observation.","PREVENTION",{"masking":45,"maskingDescription":46,"whoMasked":38},"NONE","This is an open-label study due to the nature of the intervention (radiotherapy), which does not allow blinding of participants or investigators.","Bone metastases are a common complication in patients with metastatic solid cancers and are associated with significant morbidity, including skeletal-related events (SREs) such as pathological fractures, spinal cord compression, and severe pain requiring intervention. While palliative radiotherapy is an established treatment for symptomatic bone metastases, the role of prophylactic radiotherapy in asymptomatic or minimally symptomatic high-risk lesions remains insufficiently defined.\n\nThis prospective, randomized, single-center phase II clinical trial evaluates the effectiveness of early prophylactic radiotherapy in reducing the incidence of SREs. Eligible patients with metastatic solid cancers and up to five high-risk asymptomatic or minimally symptomatic bone metastases will be randomized in a 1:1 ratio into two groups. The control group will receive standard of care systemic therapy or observation according to tumor type and clinical guidelines. The intervention group will receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to selected high-risk bone metastases in addition to standard of care.\n\nPatients will be followed from baseline up to 12 months, with assessments conducted at predefined intervals. Study outcomes include the incidence of SREs, adverse events (graded according to CTCAE), patient-reported outcomes using validated questionnaires (EORTC QLQ-C30, EQ-5D-5L, BPI), economic burden, pain-free survival, and overall survival.\n\nThis study aims to determine whether early radiotherapy intervention can prevent skeletal complications, reduce healthcare burden, and improve patient outcomes in metastatic bone disease.",[49,56],{"label":50,"type":51,"description":52,"interventionNames":53},"Prophylactic Radiotherapy + Standard of Care","EXPERIMENTAL","Participants receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to up to five high-risk asymptomatic or minimally symptomatic bone metastases, in addition to standard of care systemic therapy or observation.",[54,55],"Radiation: Prophylactic External Beam Radiotherapy","Other: Standard of Care",{"label":57,"type":58,"description":59,"interventionNames":60},"Standard of Care","ACTIVE_COMPARATOR","Participants receive standard of care systemic therapy or observation according to tumor type and clinical guidelines, without prophylactic radiotherapy.",[55],[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":38},"RADIATION","Prophylactic External Beam Radiotherapy","External beam radiotherapy delivered to up to five high-risk asymptomatic or minimally symptomatic bone metastases at a total dose of 25 Gy in 5 fractions.",[50],{"type":6,"name":57,"description":68,"armGroupLabels":69,"otherNames":38},"Systemic therapy or observation according to tumor type and clinical guidelines.",[50,57],[71,76],{"name":72,"role":73,"phone":74,"phoneExt":38,"email":75},"Eva Ćirić, MD","CONTACT","+38615879623","eciric@onko-i.si",{"name":77,"role":73,"phone":78,"phoneExt":38,"email":79},"Klavdija Korošec","+38631630065","kkorosec@onko-i.si",[81],{"facility":5,"status":82,"city":83,"state":38,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":88,"coordinates":89},"Point",[90,91],14.50513,46.05108,{"lat":91,"lon":90},[94,95],{"name":72,"role":73,"phone":74,"phoneExt":38,"email":75},{"name":77,"role":73,"phone":78,"phoneExt":38,"email":79},{"type":97,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100634512","phase-2-prophylactic-radiotherapy-to-prevent-bone-complications-in-patients-with-metastatic-solid-cancers-100634512",false,"NCT07540650","Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers","A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers","pRevenT","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)\n* Presence of up to five high-risk bone metastases\n* High-risk bone metastases defined according to protocol criteria\n* Asymptomatic or minimally symptomatic bone metastases (not requiring opioid analgesics)\n* ECOG performance status 0-2\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to the index bone metastases preventing safe treatment planning\n* Symptomatic bone metastases requiring immediate palliative radiotherapy\n* Evidence of spinal cord compression\n* Bone metastases causing significant pain requiring opioid analgesics\n* Oligometastatic disease suitable for radical treatment\n* Leptomeningeal disease\n* ECOG performance status ≥3\n* Life expectancy less than 3 months\n* Any condition that, in the investigator's opinion, would interfere with study participation or assessment","ALL","18 Years",{"count":109,"type":110},90,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.",[116,117],"Bone Metastases","Metastatic Solid Tumor",[119,120],"prophylactic radiotherapy","early radiotherapy","2026-10-06",{"date":123,"type":124},"2026-10-09","ACTUAL",{"date":126,"type":124},"2026-06-02",{"date":128,"type":110},"2029-02",{"name":5,"class":6},1]