Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04018872

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

Led by Dallas VA Medical Center · Updated on 2021-11-04

78

Participants Needed

1

Research Sites

379 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with localized (locoregional) esophageal cancer
  • Patients diagnosed with localized (locoregional) gastroesophageal junction cancer
Not Eligible

You will not qualify if you...

  • Patients unwilling or unable to provide informed consent
  • Patients with QTc >450ms
  • Patients with a history of symptomatic congestive heart failure
  • Patients with LFT's >3xULN
  • Patients who are pregnant
  • Patients with a known allergy to itraconazole

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dallas VA Medical Center

Dallas, Texas, United States, 75216

Actively Recruiting

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Research Team

D

David Wang, MD, PhD

CONTACT

T

Thai Pham, MD

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