[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553000":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":81,"collaborators":83,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":25,"enrollmentInfo":134,"targetDuration":25,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":150,"whyStopped":25,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-intensity radiological surveillance","EXPERIMENTAL","High\u002Fintermediate grade histology: 3-4 monthly CT scan up to 2-years postoperatively, 6-monthly CT scan from 2-5 years postoperatively (schedule 1)\n\nLow grade histology: 6-monthly CT scan up to 2-years postoperatively, annual CT scan from 2-5 years postoperatively (schedule 2)",[13],"Diagnostic Test: High-intensity radiological surveillance",{"label":15,"type":16,"description":17,"interventionNames":18},"Lower-intensity radiological surveillance","ACTIVE_COMPARATOR","High intermediate grade histology: 6-monthly CT scan up to 2-years postoperatively, annual CT scan from 2-5 years postoperatively (schedule 2)\n\nLow grade histology: Annual CT scan up to 2-years postoperatively, 18 monthly CT scan from 2-5 years postoperatively (schedule 3)",[19],"Diagnostic Test: Lower-intensity radiological surveillance",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","The standard approach to surveillance imaging will be contrasted CT (IV and oral contrast) of the chest, abdomen and pelvis. All patients require radiological assessment of the chest, abdomen and pelvis at each surveillance round. Tolerance will be given in the protocol for selected patients where CT is not suitable to receive alternative imaging such as MRI or combination of MRI and CT. Uncontrasted CT imaging is permissible where renal toxicity or allergy from intravenous contrast is of concern. The use of plain radiography is not permitted as an alternative to CT imaging of the chest.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Samuel Ford, PhD","samuel.ford@uhb.nhs.uk","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Marco Fiore, MD","CONTACT","022390 2910","marco.fiore@istitutotumori.mi.it",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Daniela Salvatore, PhD","022390 2796","daniela.salvatore@istitutotumori.mi.it",[44,62],{"facility":45,"status":25,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Fondazione IRCCS Istituto Nazionale dei Tumori","Milan","Lombardy","20133","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],9.18951,45.46427,{"lat":55,"lon":54},[58,59,61],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":60,"role":36,"phone":41,"phoneExt":25,"email":42},"Daniella Salvatore, PhD",{"name":35,"role":36,"phone":25,"phoneExt":25,"email":25},{"facility":63,"status":25,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University Hospitals Birmingham NHS Foundation Trust","Birmingham","West Midlands","B15 2GW","United Kingdom","UK",{"type":52,"coordinates":70},[71,72],-1.89983,52.48142,{"lat":72,"lon":71},[75,77,80],{"name":30,"role":36,"phone":76,"phoneExt":25,"email":31},"+44 121 3715880",{"name":78,"role":36,"phone":76,"phoneExt":25,"email":79},"James Glasbey, PhD","j.glasbey@bham.ac.uk",{"name":30,"role":36,"phone":25,"phoneExt":25,"email":25},{"type":82,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[84,86,88,90,92,94,96,98,100,102,104,106,108,110,112,114,116,118,120,122],{"name":85,"class":6},"University of Birmingham",{"name":87,"class":6},"University Hospital Birmingham NHS Foundation Trust",{"name":89,"class":6},"Royal Marsden NHS Foundation Trust",{"name":91,"class":6},"University Hospital Padova",{"name":93,"class":6},"Campus Bio-Medico University",{"name":95,"class":6},"The Netherlands Cancer Institute",{"name":97,"class":6},"KU Leuven",{"name":99,"class":6},"Heidelberg University",{"name":101,"class":6},"Dana-Farber\u002FBrigham and Women's Cancer Center",{"name":103,"class":6},"Emory University",{"name":105,"class":6},"Mayo Clinic",{"name":107,"class":6},"Fred Hutchinson Cancer Research Center\u002FUniversity of Washington Cancer Consortium",{"name":109,"class":6},"The Cleveland Clinic",{"name":111,"class":6},"M.D. Anderson Cancer Center",{"name":113,"class":6},"University of Southern California",{"name":115,"class":6},"Ohio State University",{"name":117,"class":6},"Ottawa Hospital Research Institute",{"name":119,"class":6},"McGill University",{"name":121,"class":6},"Peter MacCallum Cancer Centre, Australia",{"name":123,"class":6},"Royal Prince Alfred Hospital, Sydney, Australia","100553000","phase-3-high-versus-lower-intensity-surveillance-following-resection-of-retroperitoneal-sarcoma-100553000",false,"NCT06480396","High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma","An International, Partially-randomised, Patient-preference Trial Within a Registry of High Versus Lower Intensity Radiological Surveillance Following Primary Resection of Retroperitoneal, Abdominal and Pelvic Soft Tissue Sarcoma","SARveillance","Inclusion Criteria:\n\n* Adult patients (greater than 18 years)\n* Primary resection\n* Histologically confirmed retroperitoneal, abdominal or pelvic soft tissue sarcoma\n* R0\u002FR1 resection\n* Eligible whether or not the participant undergoes neoadjuvant treatment\n\nExclusion Criteria:\n\n* Metastatic disease at time of randomisation\n* Recurrent, metastatic or residual disease identified on baseline CT imaging (3-4 months post primary resection)\n* Reoperation for recurrent soft tissue sarcoma\n* Re-resection following previous inadequate surgery\n* R2 resection\n* Patients receiving adjuvant therapy that will delay, interrupt or render radiological surveillance unpredictable\n* Uterine sarcomas, gastrointestinal stromal tumour (GIST), fibromatosis, epithelial tumours, multifocal disease, sarcomas of bony origin\n* Patient declined to consent to data sharing with RESAR (unless in a centre contributing via pre-planned IPDMA)","ALL","18 Years",{"count":135,"type":136},584,"ESTIMATED","INTERVENTIONAL",[139],"PHASE3","The SARveillance trial is an efficient, pragmatic, multi-centre, international, stratified, partially-randomised, patient-preference trial within a registry of high versus lower intensity radiological surveillance following primary resection of retroperitoneal, abdominal and pelvic soft tissue sarcoma. The trial design is stratified by sarcoma tumour grade (high\u002Fintermediate grade and low grade).",[142,143],"Sarcoma,Soft Tissue","Sarcoma Retroperitoneal",[145,146,147,148,149],"Surveillance","Radiology","Surgery","Quality of life","Cost-effectiveness","NOT_YET_RECRUITING","2024-10-14",{"date":153,"type":154},"2024-10-16","ACTUAL",{"date":156,"type":136},"2024-11",{"date":158,"type":136},"2033-12",{"name":5,"class":6},2]