[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569152":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":33,"locations":42,"responsibleParty":63,"collaborators":66,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Azienda Ospedaliera di Padova","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgical Resection Arm","EXPERIMENTAL","Patients in this arm will undergo surgical resection of both the primary tumor and liver metastases. The surgical approach, extent of resection, and perioperative management will follow the standard protocols at each participating center. Venous vascular resections might be performed to reach radicality. Either standard or parenchyma sparing liver resections might be performed for resection of the liver metastases. Alternatively, needle ablation\u002Fmicrowave on the liver lesions is possible for lesions \\\u003C20 mm if technically feasible. Post-operative chemotherapy and\u002For radiotherapy could be administered as per multi-disciplinary decision based on case-by-case evaluation.",[13],"Procedure: Surgical resection of both the primary tumor and liver metastases",{"label":15,"type":16,"description":17,"interventionNames":18},"Palliative care arm","NO_INTERVENTION","Patients in this arm will continue to be treated following palliative care, consisting in observation or continuation of chemotherapy according to investigator's choice and duration of first-line chemotherapy. If required, they will continue with systemic chemotherapy, as received during the initial treatment phase, with a chemotherapy protocol based on the Institution's approved guidelines and adjusted as for clinician's choice.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Surgical resection of both the primary tumor and liver metastases","Surgical resection of both the primary tumor and liver metastases. The surgical approach, extent of resection, and perioperative management will follow the standard protocols at each participating center. Venous vascular resections might be performed to reach radicality. Either standard or parenchyma sparing liver resections might be performed for resection of the liver metastases. Alternatively, needle ablation\u002Fmicrowave on the liver lesions is possible for lesions \\\u003C20 mm if technically feasible. Post-operative chemotherapy and\u002For radiotherapy could be administered as per multi-disciplinary decision based on case-by-case evaluation.",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Giovanni Marchegiani, MD, PhD, Professor","University of Padova","STUDY_CHAIR",{"name":31,"affiliation":28,"role":32},"Umberto Cillo, Director, MD, Professor","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Giovanni Marchegiani, Medical Doctor, PhD, Professor","CONTACT","+390498212259","giovanni.marchegiani@unipd.it",{"name":40,"role":36,"phone":37,"phoneExt":18,"email":41},"Giampaolo Perri, Medical Doctor","giampaolo.perri@unipd.it",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":47,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"UOC Chirurgia Generale 2, Azienda Ospedale di Padova","RECRUITING","Padova","Italy","35128","IT",{"type":51,"coordinates":52},"Point",[53,54],11.14261,44.38225,{"lat":54,"lon":53},[57,59,60,61],{"name":58,"role":36,"phone":37,"phoneExt":18,"email":38},"Giovanni Marchegiani, MD; PhD, Professor",{"name":40,"role":36,"phone":37,"phoneExt":18,"email":41},{"name":27,"role":36,"phone":18,"phoneExt":18,"email":18},{"name":62,"role":36,"phone":18,"phoneExt":18,"email":18},"Umberto Cillo, MD, Director, Professor",{"type":32,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Prof. Umberto Cillo","Chief of General Surgery 2 Department - HBP and liver transplantion unit",[67],{"name":28,"class":6},"100569152","phase-2-conversion-surgery-vs-palliative-care-in-pancreatic-cancer-oligometastatic-to-the-liver-100569152",false,"NCT06690528","Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver","Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver (SONAR: Surgery in Oligometastatic PaNcreatic CAnceR) a Randomized Controlled Trial","SONAR","Inclusion Criteria:\n\n* Adult patients aged ≥18 years and ≤75 years (at diagnosis).\n* Cytologically or histologically confirmed pancreatic adenocarcinoma either resectable or borderline resectable (at diagnosis) according to National Comprehensive Cancer Network (NCCN)4 (see section 5).\n* Synchronous oligometastatic disease (at diagnosis), defined as a limited number of radiologically documented liver metastases (up to 3 lesions).\n* No evidence of extrahepatic metastases (at diagnosis.)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (at enrollment)\n* Partial response or stable disease after completion of first-line chemotherapy, as determined by RECIST 1.1 criteria21 (modified to exclude any % of increase in the sum of diameters of target lesions) (at enrollment).\n* Decreasing or stable (defined as ≤20% increase) serum CA19-9 level after chemotherapy (at enrollment).\n* Liver metastases considered resectable (see section 5) or alternatively treatable by needle ablation\u002Fmicrowave once no larger than 20 mm (at enrollment).\n\nExclusion Criteria:\n\n* Locally advanced pancreatic cancer according to NCCN4.\n* Unresectable liver disease (according to multidisciplinary discussion).\n* Involvement of other organs.\n* Presence of significant comorbidities precluding surgery.\n* Pregnancy.\n* Contraindications to surgical resection.\n* Prior surgical resection of the primary tumor or liver metastases.\n* Evidence of extrahepatic metastases.\n* Inability to provide informed consent or participate in follow-up assessments.\n* Disease progression as determined by RECIST 1.1 criteria21 (modified to include any % of increase in the sum of diameters of target lesions) after chemotherapy.\n* Serum CA19-9 level increase \\>20% after chemotherapy.\n\nNote: Additional specific exclusion criteria may be defined at each participating center based on their institutional guidelines and patient population.","ALL","18 Years","75 Years",{"count":80,"type":81},56,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This study investigates the impact of surgical resection compared to palliative care in patients with oligometastatic pancreatic cancer limited to the liver. Specifically, it examines whether surgery after stable disease or response to chemotherapy can improve survival and quality of life. The international, multicenter randomized trial will recruit 56 patients, assigning them to either surgical resection (including tumor and liver metastases) or ongoing palliative care with chemotherapy. Stratification by performance status, tumor markers, and tumor location will ensure balanced study groups. Outcome assessments, conducted over a minimum two-year follow-up, include clinical evaluations, imaging, and quality-of-life metric",[87],"Pancreatic Cancer Metastatic",[89,90,91,92,93,94,95],"Pancreatic Cancer Metastatic to Liver","Pancreatic Cancer Oligometastatic to Liver","Coversion Surgery Pancreatic Cancer","NEoadiuvant Therapy for Oligometastatic Pancreatic Cancer","Resectable Pancreatic Cancer","Resectable Liver Metastasis in Pancreatic Cancer","Combined Surgery for Metastatic Pancreatic Cancer","2024-11-13",{"date":98,"type":99},"2024-11-15","ACTUAL",{"date":101,"type":99},"2024-11-06",{"date":103,"type":81},"2028-11",{"name":5,"class":6},1]