[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482571":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":28,"responsibleParty":140,"collaborators":142,"id":159,"slug":160,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":18,"eligibilityCriteria":164,"healthyVolunteers":161,"sex":165,"minAge":166,"maxAge":18,"enrollmentInfo":167,"targetDuration":18,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":178,"overallStatus":31,"whyStopped":18,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"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",[29,49,64,80,96,111,125],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"VA Palo Alto Health Care System, Palo Alto, CA","RECRUITING","Palo Alto","California","94304-1207","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-122.14302,37.44188,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":46,"phoneExt":47,"email":48},"Albert Lin, MD","650-493-5000","69523","albert.lin6@va.gov",{"facility":22,"status":31,"city":50,"state":51,"zip":52,"country":35,"countryCode":36,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Ann Arbor","Michigan","48105-2303",{"type":38,"coordinates":54},[55,56],-83.74088,42.27756,{"lat":56,"lon":55},[59,63],{"name":60,"role":26,"phone":61,"phoneExt":18,"email":62},"Laura A Randolph, BA","734-845-5091","Laura.Randolph@va.gov",{"name":21,"role":23,"phone":18,"phoneExt":18,"email":18},{"facility":65,"status":31,"city":66,"state":67,"zip":68,"country":35,"countryCode":36,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705-3875",{"type":38,"coordinates":70},[71,72],-78.89862,35.99403,{"lat":72,"lon":71},[75],{"name":76,"role":26,"phone":77,"phoneExt":78,"email":79},"Michael Kelley, MD","919-286-0411","172199","michael.kelley6@va.gov",{"facility":81,"status":31,"city":82,"state":83,"zip":84,"country":35,"countryCode":36,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"VA Portland Health Care System, Portland, OR","Portland","Oregon","97207-2964",{"type":38,"coordinates":86},[87,88],-122.67621,45.52345,{"lat":88,"lon":87},[91],{"name":92,"role":26,"phone":93,"phoneExt":94,"email":95},"Kenneth Bensch, MD","503-220-8262","5594","kenneth.bensch1@va.gov",{"facility":97,"status":31,"city":98,"state":99,"zip":100,"country":35,"countryCode":36,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","Dallas","Texas","75216-7167",{"type":38,"coordinates":102},[103,104],-96.80667,32.78306,{"lat":104,"lon":103},[107],{"name":108,"role":26,"phone":109,"phoneExt":18,"email":110},"Nicole Pore-Brown","214-857-3291","Florine.Pore-Brown@va.gov",{"facility":112,"status":31,"city":113,"state":99,"zip":114,"country":35,"countryCode":36,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","77030-4211",{"type":38,"coordinates":116},[117,118],-95.36327,29.76328,{"lat":118,"lon":117},[121],{"name":122,"role":26,"phone":123,"phoneExt":18,"email":124},"Yvonne Sada, MD","713-794-7454","yvonne.sada@va.gov",{"facility":126,"status":31,"city":127,"state":128,"zip":129,"country":35,"countryCode":36,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"VA Puget Sound Health Care System Seattle Division, Seattle, WA","Seattle","Washington","98108-1532",{"type":38,"coordinates":131},[132,133],-122.33207,47.60621,{"lat":133,"lon":132},[136],{"name":137,"role":26,"phone":138,"phoneExt":18,"email":139},"Daniel Wu, MD","206-764-2182","daniel.wu@va.gov",{"type":141,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[143,145,147,149,151,153,155,157],{"name":144,"class":6},"Durham VA Health Care System",{"name":146,"class":6},"VA Palo Alto Health Care System",{"name":148,"class":6},"Portland VA Medical Center",{"name":150,"class":6},"VA Puget Sound Health Care System",{"name":152,"class":6},"Michael E. DeBakey VA Medical Center",{"name":154,"class":6},"VA Boston Healthcare System",{"name":156,"class":6},"North Texas Veterans Healthcare System",{"name":158,"class":6},"VA Ann Arbor Healthcare System","100482571","phase-2-a-phase-ii-trial-to-evaluate-the-effect-of-itraconazole-on-pathologic-complete-response-rates-in-resectable-esophageal-cancer-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":168,"type":169},78,"ESTIMATED","INTERVENTIONAL",[172],"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.",[175,176,177],"Esophageal Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Gastroesophageal Junction Carcinoma",[9,179],"Neoadjuvant","2025-11-03",{"date":182,"type":183},"2025-11-05","ACTUAL",{"date":185,"type":183},"2024-10-01",{"date":187,"type":169},"2029-06-15",{"name":5,"class":6},7]