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

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 or chemoimmunotherapy and surgery in the the treatment of locoregional esophageal and gastroesophageal junct

Trial Details

NCT ID
NCT05563766
Phase
PHASE2
Sponsor
VA Office of Research and Development
Status
RECRUITING
Cancer Type
Esophageal Cancer
Interventions
  • Itraconazole
Locations (sample)
  • Palo Alto, California, United States|37.44188,-122.14302
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • Durham, North Carolina, United States|35.99403,-78.89862
  • Portland, Oregon, United States|45.52345,-122.67621
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility 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 chemoradiat…
  • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 at enrollment
  • Adequate renal and liver function as judged by the treating physician

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Esophageal Cancer Trials on Trialify →