[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100322927":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":26,"studyPopulation":18,"armGroups":27,"interventions":35,"overallOfficials":49,"centralContacts":53,"locations":58,"responsibleParty":75,"collaborators":18,"id":78,"slug":18,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":18,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":18,"enrollmentInfo":86,"targetDuration":18,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":18,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Louisville","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)","Adverse and Serious Adverse events will be collected and analyzed","Time from first dose until subject has reached 90 days post last active study treatment",[14],{"measure":15,"description":16,"timeFrame":17},"Progression free survival","Triphase CT scan will be performed within one month of IRE procedure. Triphase CT scans will then be obtained every 3 months to check disease status.","Time from first dose date to first date of confirmed disease progression, assessed for 90 days",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"NA","SINGLE_GROUP","All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)","TREATMENT",{"masking":25,"maskingDescription":18,"whoMasked":18},"NONE","Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.",[28],{"label":29,"type":6,"description":30,"interventionNames":31},"Treatment","Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)",[32,33,34],"Procedure: Irreversible Electroporation (IRE)","Drug: Gemcitabine","Drug: FOLFIRINOX",[36,41,46],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":18},"PROCEDURE","Irreversible Electroporation (IRE)","Non-thermal ablation of tumor",[29],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":18},"DRUG","Gemcitabine","25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled",[29],{"type":42,"name":47,"description":44,"armGroupLabels":48,"otherNames":18},"FOLFIRINOX",[29],[50],{"name":51,"affiliation":5,"role":52},"Robert Martin, MD, PhD","PRINCIPAL_INVESTIGATOR",[54],{"name":51,"role":55,"phone":56,"phoneExt":18,"email":57},"CONTACT","502-629-3355","robert.martin@louisville.edu",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-85.75941,38.25424,{"lat":70,"lon":69},[73,74],{"name":51,"role":55,"phone":56,"phoneExt":18,"email":57},{"name":51,"role":52,"phone":18,"phoneExt":18,"email":18},{"type":52,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Robert C. Martin","Principal Investigator","100322927",false,"NCT03484299","Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma","Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* greater than or equal to 18 years of age\n* diagnosed with stage III pancreatic cancer\n* tumor is measurable\n* GFR \\> mL\u002Fmin\u002F1.73m2\n* willing and able to comply with protocol requirements\n* AST\u002FALT \\>3 times upper limit of normal\n* stable surgical post-operative course as defined by operative surgeon\n\nExclusion Criteria:\n\n* participating in another clinical trial for the treatment of cancer at the time of screening\n* pregnant or currently breast feeding\n* have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure\n* have non-removable implants with metal parts within 1 cm of the target lesion\n* had a myocardial infarction within 3 months prior to enrollment","ALL","18 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.",[94],"Pancreas Cancer","2025-10-27",{"date":97,"type":98},"2025-10-29","ACTUAL",{"date":100,"type":98},"2018-05-30",{"date":102,"type":88},"2027-07-31",{"name":5,"class":6},1]