[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614895":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective, interventional, monocentric, clinical study of SBRT for primary\u002Fsecondary renal tumor","EXPERIMENTAL","SBRT to renal lesions will be delivered using 1-5 fractions. Dose and fractionation options will attempt to keep the biologically effective dose (BED) to ≥80 Gy assuming an α\u002Fβ ratio of 10 due to association with improved local control. Established dosing regimens include:\n\n* 25-26 Gy in 1 fraction, for lesion in the greatest diameter (or sum of diameters in case of multiple lesions) up to 4 cm of maximum diameter\n* 42-48 Gy in 3-4 fractions, for lesion in the greatest diameter (or sum of diameters in case of multiple lesions) up to 6 cm of maximum diameter\n* 40-50 Gy in 5 fractions, for lesion larger than 6 cm in the greatest diameter (or sum of diameters in case of multiple lesions) For multi-fraction dosing, treatment will be delivered on consecutive or alternate days.",[13],"Radiation: Stereotactic body radiotherapy (SBRT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Stereotactic body radiotherapy (SBRT)","SBRT for primary or secondary renal tumors, delivering from 25-26 Gy\u002F1 fraction to 42-48 Gy\u002F3-4 fractions or 40-50 Gy\u002F5 fractions (according to tumor size), using CyberKnife",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Nadia G Di Muzio, Prof.","IRCCS San Raffaele Scientific Institute","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Andrei Fodor, MD","CONTACT","+39 0226437634","fodor.andrei@hsr.it",{"name":23,"role":29,"phone":33,"phoneExt":20,"email":34},"+390226437643","dimuzio.nadia@hsr.it",[36],{"facility":37,"status":20,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute","Milan","Milano (MI)","20073","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],12.59836,42.78235,{"lat":47,"lon":46},[50],{"name":20,"role":29,"phone":51,"phoneExt":20,"email":20},"3204432312",{"type":25,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Nadia Di Muzio","Professor","100614895","stereotactic-body-radiotherapy-with-continuous-tracking-for-primary-and-secondary-renal-cancer-100614895",false,"NCT07285538","Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer","A Prospective Interventional Study of Stereotactic Body RadioTherapy (SBRT) With Continuous Tracking for Inoperable Patients With Primary and Secondary Renal Cancer (SBRTRC)","SBRTRC","Inclusion Criteria:\n\n1. Histological or clinical diagnosis of primary or secondary kidney tumors\n2. Patients aged ≥18 years\n3. Signed informed consent\n4. Tumor up to 10 cm in the greatest diameter (sum of diameters in case of multiple lesions)\n5. PS (ECOG) ≤2\n6. No prior local radiotherapy\n7. Fertile women using contraception methods previously initiated (a pregnancy test will be prescribed)\n\nExclusion Criteria:\n\n1. Patients aged \\\u003C 18 years\n2. Tumors \\> 10 cm\n3. PS ECOG ≥3\n4. Psychiatric or other disorders that may prevent the patient from signing informed consent\n5. Previous invasive cancer, except for skin cancer (excluding melanoma) unless the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the oral cavity or bladder)\n6. Pregnant women\n7. Collagen diseases\n8. Sjogren's syndrome","ALL","18 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"NA","This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy\u002F1 fraction to 42-48 Gy\u002F3-4 fractions or 40-50 Gy\u002F5 fractions (standard prescriptions for the internationl guidelines, according to tumor size), using a robotic accelerator -CyberKnife® (Accuray, Sunnyvale, CA)-, with fiducial-tracking, to observe the acute and late toxicity reduction (as primary objectives), due to the maximum precision of the treatment. Secondary objectives are Local Relpase-Free Survival (LRFS), Regional Relapse-Free Survival (RRFS), Distant Metastasis-Free Survival (DMFS), Disease-Free Survival (DFS), Cancer Specific Survival (CSS), Overall Survival (OS) and Quality-of-Life (QoL). A total of 60 participants are expected to be enrolled over four years, and the follow-up of enrolled patients will be three years.",[73,74,75],"Renal Cancer","Renal Secondary Cancer","Stereotactic Body Radiotherapy",[77,78,79,80,81],"Renal primary tumors","Renal secondary tumors","stereotactic body radiotherapy","stereotactic ablative radiotherapy","Renal toxicity","NOT_YET_RECRUITING","2025-12-12",{"date":85,"type":86},"2025-12-16","ACTUAL",{"date":88,"type":67},"2026-01-15",{"date":90,"type":67},"2033-01-15",{"name":5,"class":6},1]