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RECRUITING Phase 2

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

NCT05563766 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Itraconazole

Study Locations (7)

Texas

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas
  • Michael E. DeBakey VA Medical Center, Houston, TX — Houston

California

  • VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto

Michigan

  • VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor

North Carolina

  • Durham VA Medical Center, Durham, NC — Durham

Oregon

  • VA Portland Health Care System, Portland, OR — Portland

Washington

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2024-10-01
Est. Completion 2029-06-15
Phase Phase 2

Sponsor

VA Office of Research and Development

1,863 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05563766

The ClinicalTrials.gov registry entry for NCT05563766 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention — of which Itraconazole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05563766 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Texas, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05563766 about?

NCT05563766 is a clinical study titled "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, effec...

What is the current status of trial NCT05563766?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2024-10-01. Estimated completion is 2029-06-15.

What conditions does trial NCT05563766 study?

This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Junction Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05563766?

The interventions under investigation include: Itraconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05563766?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05563766 being conducted?

This trial has 7 study locations across California, Michigan, North Carolina, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial