RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2019-06-24
Study Completion:2026-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04018872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed with localized (locoregional) esophageal cancer
  2. * Patients diagnosed with localized (locoregional) gastroesophageal junction cancer
  1. * Patients unwilling or unable to provide informed consent
  2. * Patients with QTc\>450ms
  3. * Patients with a history of symptomatic congestive heart failure
  4. * Patients with LFT's\>3xULN
  5. * Patients who are pregnant
  6. * Patients with a known allergy to itraconazole

Contacts and Locations

Study Contact

David Wang, MD, PhD
CONTACT
214-857-0737
davidh.wang@va.gov
Thai Pham, MD
CONTACT
214-857-1800
thai.pham2@va.gov

Principal Investigator

David Wang, MD, PhD
PRINCIPAL_INVESTIGATOR
North Texas Veterans Healthcare System

Study Locations (Sites)

Dallas VA Medical Center
Dallas, Texas, 75216
United States

Collaborators and Investigators

Sponsor: Dallas VA Medical Center

  • David Wang, MD, PhD, PRINCIPAL_INVESTIGATOR, North Texas Veterans Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-24
Study Completion Date2026-09-29

Study Record Updates

Study Start Date2019-06-24
Study Completion Date2026-09-29

Terms related to this study

Keywords Provided by Researchers

  • itraconazole
  • esophageal neoplasms
  • esophagus
  • esophagogastric junction
  • adenocarcinoma
  • squamous cell carcinoma

Additional Relevant MeSH Terms

  • Esophagus Adenocarcinoma
  • Esophagus Squamous Cell Carcinoma
  • Gastroesophageal Junction Adenocarcinoma