[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610059":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":23,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":23,"enrollmentInfo":72,"targetDuration":23,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":42,"whyStopped":23,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Liquid Nitrogen Spray Cryotherapy (LNSC) + Standard of care chemotherapy","EXPERIMENTAL","Participants will receive a standard of care chemotherapy, neoadjuvant FLOT +\u002F- durvalumab WITH LNSC.",[13,14],"Other: Standard of care chemotherapy","Procedure: LNSC",{"label":16,"type":6,"description":17,"interventionNames":18},"Standard of care chemotherapy","Participants will receive a standard of care chemotherapy, neoadjuvant FLOT +\u002F- durvalumab WITHOUT LNSC.",[13],[20,24],{"type":6,"name":16,"description":21,"armGroupLabels":22,"otherNames":23},"Participants will receive neoadjuvant therapy per FLOT protocol +\u002F- Durvalumab for up to 6 cycles. Each cycle is two weeks.\n\nThe FLOT protocol is a standard of care protocol involving chemotherapy before and after esophagectomy with fluorouracil, leucovorin, oxaliplatin, and docetaxel.\n\nDurvalumab is administered intravenously (IV) and dosed at 1500 milligrams (mg). It is given on Day 1 of each cycle.",[9,16],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"PROCEDURE","LNSC","LNSC will be administered via endoscopy. LNSC will be performed with liquid nitrogen (\\\u003C5 psi) at 25 watts using a cryotherapy catheter passed through the working channel of the endoscope. Up to three cycles of 20 to 40 seconds of cryotherapy will be administered and each directed at the bulkiest aspect of the tumor. During each cycle, a surface area of approximately 2 to 3 cm2 is targeted, and up to three sites are targeted during each session.\n\nParticipants will receive two sessions of LNSC. The first will be upon entry into the study. The second will be 1-2 weeks after the first session.",[9],[30],{"name":31,"affiliation":32,"role":33},"Tilak Shah, MD","Case Comprehensive Cancer Center, Cleveland Clinic Florida","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":23,"email":38},"CONTACT","561-497-8859","shaht3@ccf.org",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Cleveland Clinic Florida","RECRUITING","Weston","Florida","33331","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-80.39977,26.10037,{"lat":52,"lon":51},[55,56],{"name":31,"role":36,"phone":23,"phoneExt":23,"email":23},{"name":31,"role":33,"phone":23,"phoneExt":23,"email":23},{"type":58,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[60],{"name":61,"class":62},"Salgi Foundation","UNKNOWN","100610059","phase-2-liquid-nitrogen-spray-cryotherapy-prior-to-neoadjuvant-systemic-therapy-in-esophageal-adenocarcinoma-100610059",false,"NCT07222657","Liquid Nitrogen Spray Cryotherapy Prior to Neoadjuvant Systemic Therapy in Esophageal Adenocarcinoma","Phase 2 Randomized Trial Of Liquid Nitrogen Spray Cryotherapy Prior To Neoadjuvant Systemic Therapy In Locally Advanced Esophageal Adenocarcinoma","Inclusion Criteria:\n\n* Adults with locally advanced EAC who are expected to receive FLOT +\u002F-Durvalumab will be eligible to participate.\n* Locally advanced esophageal cancer is defined as TNM stages T1N+M0 or T2-T4aNanyM0, as defined by endoscopic ultrasound (EUS) and PET-CT.\n\nExclusion Criteria:\n\n* Inability to pass the orogastric decompression tube into the stomach\n* Coagulopathy (INR \\> 2 or platelet count \\\u003C 50,000 per cubic millimeter)\n* Inability to provide informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 2\n* Risk of thrombosis is determined to be too high to hold anti-platelets (other than aspirin) or anticoagulants prior to the procedure.","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","This research study is for people who have locally advanced esophageal adenocarcinoma and are expected to receive chemotherapy. The purpose of this study is to compare the effectiveness of Liquid Nitrogen Spray Cryotherapy (LNSC) in addition to chemotherapy versus chemotherapy alone in the treatment of esophageal adenocarcinoma. LNSC is an FDA approved device that works by using liquid nitrogen to rapidly cool cancerous tissue causing cell damage. Participants in this study will be randomly assigned to either the \"LNSC group\" or the \"No-LNSC group.\" Participants in the \"LNSC group\" will undergo 2 sessions of LNSC through an upper endoscopy. Participants in the \"No-LNSC group,\" may undergo an endoscopy if needed for symptoms such as difficulty swallowing. Participation in the research will last about 4 months.",[80,81],"Esophageal Adenocarcinoma","Esophageal Cancer",[83,26],"Liquid Nitrogen Spray Cryotherapy","2026-08-17",{"date":86,"type":87},"2026-08-18","ACTUAL",{"date":89,"type":87},"2026-06-10",{"date":91,"type":74},"2027-09",{"name":5,"class":6},1]