Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06732388
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This phase II trial tests how well itraconazole works in combination with the usual standard of care endoscopy with ablation for the prevention of esophageal cancer in patients who have high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes and 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. 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.
Interventions
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Biopsy Procedure
(Procedure)
Undergo tissue biopsy
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Biospecimen Collection
(Procedure)
Undergo blood sample collection
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Endoscopic Procedure
(Procedure)
Undergo endoscopy
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Itraconazole
(Drug)
Given PO
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Placebo Administration
(Drug)
Given PO
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Questionnaire Administration
(Other)
Ancillary studies
-
Radiofrequency Ablation
(Procedure)
Undergo radiofrequency ablation
Eligibility criteria
Conditions
Locations
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Case Western Reserve University — Cleveland, Ohio, United States
- Baylor University Medical Center — Dallas, Texas, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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