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Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

StatusRecruiting
PhasePhase 2
Started2019-06-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 4, 2021 (before its estimated June 24, 2026 completion). Its status may not reflect the trial's current state.
Esophageal cancer, which has a low 5-year overall survival rate for all stages (\<20%) , is increasing in incidence. Previous studies have shown that the Hedgehog (Hh) and AKT signaling pathways are activated in a significant proportion of esophageal cancers. Itraconazole, a widely used anti-fungal medication, has been shown to inhibit various pathways involved in esophageal cancer tumorigenesis including Hh and AKT. In this phase II clinical trial, the investigators aim to evaluate the effect of itraconazole as a neoadjuvant therapy following standard of care chemoradiation in the treatment of locoregional esophageal and gastroesophageal junction carcinomas.

Amendment record

Amended 3 times since 2019-07-10; most recent filed 2021-11-02. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2021-11-02
Amendment Study Status v3
2020-07-20
Amendment Study Status v2
2019-07-16
Amendment Study Identification, Study Status, Study Description, Eligibility v1
2019-07-10
Original filing
Trial Details
NCT Number NCT04018872
Lead Sponsor Dallas VA Medical Center
Conditions Esophagus Adenocarcinoma, Esophagus Squamous Cell Carcinoma, Gastroesophageal Junction Adenocarcinoma
Enrollment 78 participants
Start Date 2019-06-24
Primary Completion 2026-06-24 (estimated)
Study Completion 2026-09-29 (estimated)
Updated on ClinicalTrials.gov 2021-11-04