Sponsor
National Cancer Institute (NCI)
Status
Not yet recruiting
NCT ID
NCT06732388
This phase II trial tests how well itraconazole works in combination with standard of care endoscopy with ablation for the prevention of esophageal cancer in patients with high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes. The tissue that lines the esophagus becomes more like the tissue that lines the intestine. People with Barrett's esophagus have a higher risk of developing esophageal cancer. Itraconazole is a drug used to prevent or treat fungal infections. It belongs to the family of drugs called antifungal agents. Ablation refers to the removal of abnormal tissue using heat. Endoscopy is a procedure for looking at the esophagus using a long, flexible tube called an endoscope, which has a video camera at the end. Radiofrequency ablation is a type of heat therapy that uses radiofrequency energy (similar to microwave heat) to destroy the abnormal tissue in the esophagus. Giving itraconazole in combination with standard of care endoscopy with ablation may improve the effects of ablation and prevent esophageal cancer in patients with high-risk Barrett's esophagus.
Intervention
Biopsy Procedure, Biospecimen Collection, Endoscopic Procedure, Itraconazole, Placebo Administration, Questionnaire Administration, Radiofrequency Ablation
Condition
Barrett Esophagus, Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8, Esophageal Adenocarcinoma
Investigators
Ajay Bansal, Amitabh Chak, Dayna S. Early, Prashanthi Thota, Scott M. Schuetze, Nicholas J. Shaheen, Vani Konda