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

Conditions

• Barrett Esophagus
• Clinical Stage I Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
• Esophageal Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo tissue biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Endoscopic Procedure — PROCEDURE
  Undergo endoscopy
• Itraconazole — DRUG
  Given PO
• Placebo Administration — DRUG
  Given PO
• Questionnaire Administration — OTHER
  Ancillary studies
• Radiofrequency Ablation — PROCEDURE
  Undergo radiofrequency ablation

Study Details

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.

Key Dates

Start date

Oct 6, 2026

Status verified

Apr 2026

Primary completion

Feb 1, 2030

Completion

Feb 1, 2030

Study Design

Enrollment

64 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group I (itraconazole)
  Patients receive itraconazole PO twice daily (BID) on days 1-42 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles as long as there is an absence of disease progression or unacceptable toxicity. Patients undergo usual standard of care endoscopy and radiofrequency ablation on study. Patients also undergo blood sample collection throughout the study as well as tissue biopsy on study.
• Placebo Comparator: Group II (placebo)
  Patients receive placebo PO BID on days 1-42 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles as long as there is an absence of disease progression or unacceptable toxicity. Patients undergo usual standard of care endoscopy and radiofrequency ablation on study. Patients also undergo blood sample collection throughout the study as well as tissue biopsy on study.

Primary Outcome Measure

Time to complete resolution of intestinal metaplasia (CRIM) in days [ Time Frame: Between day 1, cycle 1 (1 cycle = 6 weeks) and the date of endoscopy at which the participant is deemed to reach CRIM ]

Locations (6)

Find similar trials in Kansas City, KS

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