Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

January 2, 2028

Study Completion Date

January 2, 2028

Conditions
Barrett EsophagusClinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Esophageal Adenocarcinoma
Interventions
PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Endoscopic Procedure

Undergo endoscopy

DRUG

Itraconazole

Given PO

DRUG

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Radiofrequency Ablation

Undergo radiofrequency ablation

Trial Locations (7)

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

44106

Case Western Reserve University, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Cancer Center, Kansas City

75246

Baylor University Medical Center, Dallas

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH