[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482571":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":28,"responsibleParty":139,"collaborators":141,"id":158,"slug":18,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":18,"eligibilityCriteria":162,"healthyVolunteers":159,"sex":163,"minAge":164,"maxAge":18,"enrollmentInfo":165,"targetDuration":18,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":31,"whyStopped":18,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Itraconazole","EXPERIMENTAL","Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation",[13],"Drug: Itraconazole",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"affiliation":22,"role":23},"David H Wang, MD PhD","VA Ann Arbor Healthcare System, Ann Arbor, MI","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":18,"phoneExt":18,"email":27},"CONTACT","davidh.wang@va.gov",[29,48,63,79,95,110,124],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"VA Palo Alto Health Care System, Palo Alto, CA","RECRUITING","Palo Alto","California","94304-1207","United States",{"type":37,"coordinates":38},"Point",[39,40],-122.14302,37.44188,{"lat":40,"lon":39},[43],{"name":44,"role":26,"phone":45,"phoneExt":46,"email":47},"Albert Lin, MD","650-493-5000","69523","albert.lin6@va.gov",{"facility":22,"status":31,"city":49,"state":50,"zip":51,"country":35,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Ann Arbor","Michigan","48105-2303",{"type":37,"coordinates":53},[54,55],-83.74088,42.27756,{"lat":55,"lon":54},[58,62],{"name":59,"role":26,"phone":60,"phoneExt":18,"email":61},"Laura A Randolph, BA","734-845-5091","Laura.Randolph@va.gov",{"name":21,"role":23,"phone":18,"phoneExt":18,"email":18},{"facility":64,"status":31,"city":65,"state":66,"zip":67,"country":35,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705-3875",{"type":37,"coordinates":69},[70,71],-78.89862,35.99403,{"lat":71,"lon":70},[74],{"name":75,"role":26,"phone":76,"phoneExt":77,"email":78},"Michael Kelley, MD","919-286-0411","172199","michael.kelley6@va.gov",{"facility":80,"status":31,"city":81,"state":82,"zip":83,"country":35,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"VA Portland Health Care System, Portland, OR","Portland","Oregon","97207-2964",{"type":37,"coordinates":85},[86,87],-122.67621,45.52345,{"lat":87,"lon":86},[90],{"name":91,"role":26,"phone":92,"phoneExt":93,"email":94},"Kenneth Bensch, MD","503-220-8262","5594","kenneth.bensch1@va.gov",{"facility":96,"status":31,"city":97,"state":98,"zip":99,"country":35,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","Dallas","Texas","75216-7167",{"type":37,"coordinates":101},[102,103],-96.80667,32.78306,{"lat":103,"lon":102},[106],{"name":107,"role":26,"phone":108,"phoneExt":18,"email":109},"Nicole Pore-Brown","214-857-3291","Florine.Pore-Brown@va.gov",{"facility":111,"status":31,"city":112,"state":98,"zip":113,"country":35,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","77030-4211",{"type":37,"coordinates":115},[116,117],-95.36327,29.76328,{"lat":117,"lon":116},[120],{"name":121,"role":26,"phone":122,"phoneExt":18,"email":123},"Yvonne Sada, MD","713-794-7454","yvonne.sada@va.gov",{"facility":125,"status":31,"city":126,"state":127,"zip":128,"country":35,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"VA Puget Sound Health Care System Seattle Division, Seattle, WA","Seattle","Washington","98108-1532",{"type":37,"coordinates":130},[131,132],-122.33207,47.60621,{"lat":132,"lon":131},[135],{"name":136,"role":26,"phone":137,"phoneExt":18,"email":138},"Daniel Wu, MD","206-764-2182","daniel.wu@va.gov",{"type":140,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[142,144,146,148,150,152,154,156],{"name":143,"class":6},"Durham VA Health Care System",{"name":145,"class":6},"VA Palo Alto Health Care System",{"name":147,"class":6},"Portland VA Medical Center",{"name":149,"class":6},"VA Puget Sound Health Care System",{"name":151,"class":6},"Michael E. DeBakey VA Medical Center",{"name":153,"class":6},"VA Boston Healthcare System",{"name":155,"class":6},"North Texas Veterans Healthcare System",{"name":157,"class":6},"VA Ann Arbor Healthcare System","100482571",false,"NCT05563766","A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant chemoradiation and curative intent esophagectomy\n* World Health Organization (WHO)\u002FECOG performance status (PS) of 0-2 at enrollment\n* Adequate renal and liver function as judged by the treating physician\n\nExclusion Criteria:\n\n* Inability to provide Informed Consent\n* NYHA class III or IV CHF\n* LFT\\>3X upper limit of normal\n* Drug allergy to itraconazole\n* Positive pregnancy test\n* Those with QTc\\>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant","ALL","18 Years",{"count":166,"type":167},78,"ESTIMATED","INTERVENTIONAL",[170],"PHASE2","Esophageal cancer, which has a low 5-year overall survival rate (\\\u003C20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.",[173,174,175],"Esophageal Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Gastroesophageal Junction Carcinoma",[9,177],"Neoadjuvant","2025-11-03",{"date":180,"type":181},"2025-11-05","ACTUAL",{"date":183,"type":181},"2024-10-01",{"date":185,"type":167},"2029-06-15",{"name":5,"class":6},7]