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

NCT05563766 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-11-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Itraconazole

Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation

Sponsors & Collaborators

  • Durham VA Health Care System

    collaborator FED

  • VA Palo Alto Health Care System

    collaborator FED

  • Portland VA Medical Center

    collaborator FED

  • VA Puget Sound Health Care System

    collaborator FED

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • VA Boston Healthcare System

    collaborator FED

  • North Texas Veterans Healthcare System

    collaborator FED

  • VA Ann Arbor Healthcare System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2029-04-30
Completion
2029-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563766 on ClinicalTrials.gov