RECRUITING

A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable 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 (\<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.

Official Title

A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer

Quick Facts

Study Start:2024-10-01
Study Completion:2029-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05563766

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. * Capable of giving informed consent
  2. * 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
  3. * World Health Organization (WHO)/ECOG performance status (PS) of 0-2 at enrollment
  4. * Adequate renal and liver function as judged by the treating physician
  1. * Inability to provide Informed Consent
  2. * NYHA class III or IV CHF
  3. * LFT\>3X upper limit of normal
  4. * Drug allergy to itraconazole
  5. * Positive pregnancy test
  6. * Those with QTc\>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant

Contacts and Locations

Study Contact

David H Wang, MD PhD
CONTACT
davidh.wang@va.gov

Principal Investigator

David H Wang, MD PhD
PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Locations (Sites)

VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • David H Wang, MD PhD, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

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 Date2024-10-01
Study Completion Date2029-06-15

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2029-06-15

Terms related to this study

Keywords Provided by Researchers

  • Itraconazole
  • Neoadjuvant

Additional Relevant MeSH Terms

  • Esophageal Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma
  • Gastroesophageal Junction Carcinoma