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RECRUITING
NCT04018872
PHASE2

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

Sponsor: Dallas VA Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Trial Evaluating the Effectiveness of Itraconazole in Improving Pathologic Complete Response Rates in Patients With Esophageal Cancer Through Inhibition of the Hedgehog and AKT Signaling Pathways

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2019-06-24

Completion Date

2026-09-29

Last Updated

2021-11-04

Healthy Volunteers

No

Interventions

DRUG

Itraconazole

Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.

Locations (1)

Dallas VA Medical Center

Dallas, Texas, United States