Actively Recruiting
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Led by VA Office of Research and Development · Updated on 2025-11-05
78
Participants Needed
7
Research Sites
245 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
D
Durham VA Health Care System
Collaborating Sponsor
AI-Summary
What this Trial Is About
Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.
CONDITIONS
Official Title
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of giving informed consent
- Pathologic diagnosis of esophageal squamous cell carcinoma, esophageal adenocarcinoma, or gastroesophageal junction cancer deemed resectable by a surgeon with plan for neoadjuvant chemoradiation and curative esophagectomy
- WHO/ECOG performance status of 0 to 2 at enrollment
- Adequate renal and liver function as judged by treating physician
You will not qualify if you...
- Unable to provide informed consent
- New York Heart Association class III or IV congestive heart failure
- Liver function tests greater than 3 times the upper limit of normal
- Allergy to itraconazole
- Positive pregnancy test
- QTc interval greater than 450 ms unless monitored by serial EKG to ensure no significant prolongation during therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Actively Recruiting
2
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Actively Recruiting
3
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
4
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97207-2964
Actively Recruiting
5
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Actively Recruiting
6
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
7
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Actively Recruiting
Research Team
D
David H Wang, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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