A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Recruiting
Phase 2
Interventional Study
Esophageal Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Gastroesophageal Junction Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- VA Office of Research and Development · Federal
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Capable of giving informed consent
* Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant chemoradiation and curative intent esophagectomy
* World Health Organization (WHO)/ECOG performance stat…
Contacts