RecruitingPhase 2NCT05563766

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


Sponsor

VA Office of Research and Development

Enrollment

78 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding itraconazole — an antifungal medication — to standard chemotherapy and radiation treatment before surgery can improve outcomes in patients with esophageal or stomach junction cancer. Lab studies suggest itraconazole may make cancer cells more sensitive to chemo and radiation. **You may be eligible if...** - You have been diagnosed with esophageal cancer (squamous cell or adenocarcinoma) or gastroesophageal junction cancer - Your cancer is operable (removable by surgery) and your surgeon plans to do so - You are planned to receive standard chemotherapy and radiation before surgery - You are in adequate general health (WHO/ECOG performance status 0–2) - Your kidney and liver function are satisfactory **You may NOT be eligible if...** - You have severe heart failure (NYHA Class III or IV) - Your liver tests are more than 3 times the normal upper limit - You have a known allergy to itraconazole - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGItraconazole

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


Locations(7)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

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

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05563766


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