[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420866":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":32,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Electrochemotherapy of gynecological cancers","EXPERIMENTAL",null,[13],"Combination Product: Electrochemotherapy with bleomycin or cisplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Electrochemotherapy with bleomycin or cisplatin","Electrochemotherapy with cisplatin or bleomycin of gynecological cancers",[9],[21],"Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Gregor Serša, PhD","CONTACT","+386 1 5879 434","gsersa@onko-i.si",{"name":29,"role":25,"phone":30,"phoneExt":11,"email":31},"Maja Čemažar, PhD","+386 1 5879 544","mcemazar@onko-i.si",[33],{"facility":34,"status":35,"city":36,"state":11,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Institute of oncology Ljubljna","RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":41,"coordinates":42},"Point",[43,44],14.50513,46.05108,{"lat":44,"lon":43},[47,50,52,55,58,60,61,62,64],{"name":48,"role":25,"phone":49,"phoneExt":11,"email":27},"Gregor Sersa, PhD","+386-1-5879-544",{"name":51,"role":25,"phone":11,"phoneExt":11,"email":31},"Maja Cemazar, PhD",{"name":53,"role":54,"phone":11,"phoneExt":11,"email":11},"Barbara Šegedin, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":56,"role":57,"phone":11,"phoneExt":11,"email":11},"Helena Barbara Zobec Logar, MD, MSc","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":11,"phoneExt":11,"email":11},"Manja Šešek, MD",{"name":24,"role":57,"phone":11,"phoneExt":11,"email":11},{"name":29,"role":57,"phone":11,"phoneExt":11,"email":11},{"name":63,"role":57,"phone":11,"phoneExt":11,"email":11},"Maša Bošnjak, MPharm, PhD",{"name":65,"role":57,"phone":11,"phoneExt":11,"email":11},"Tjaša Pečnik, BSc",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100420866","phase-2-electrochemotherapy-of-gynecological-cancers-100420866",false,"NCT04760327","Electrochemotherapy of Gynecological Cancers","GynECT","Inclusion Criteria:\n\n1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.\n2. Age more than 18.\n3. Life expectancy more than 3 month.\n4. Performance status Karnofsky ≥ 70 or WHO \\\u003C or 2.\n5. Treatment free interval minimum 2 weeks.\n6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.\n7. Patient must give informed consent.\n8. Patient must be discussed at the multidisciplinary team before entering the trial.\n9. Patient should be suitable for anesthesia.\n\nExclusion Criteria:\n\n1. Visceral, bone or diffuse metastases.\n2. Life-threatening infection and\u002For heart failure and\u002For liver failure and\u002For other severe systemic pathologies.\n3. Significant reduction in respiratory function.\n4. Age less than 18 years.\n5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).\n6. Cumulative dose of ≥ 400 mg\u002Fm2 bleomycin received.\n7. Impaired kidney function (creatinin \\> 150 µmol\u002Fl).\n8. Patients with epilepsy.\n9. Pregnancy.\n10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.","FEMALE","18 Years","105 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and\u002For regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.",[86],"Gynecological Cancers",[88,89,90],"Electrochemotherapy","Cisplatin","Bleomycin","2024-10-16",{"date":93,"type":94},"2024-10-17","ACTUAL",{"date":96,"type":94},"2020-07-01",{"date":98,"type":80},"2025-12-31",{"name":5,"class":6},1]