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

RecruitingPhase 2Ages 18 Years - anyAllVA Office of Research and Development
NCT05563766 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 junction cancers.

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📋 Eligibility rules (as published)
Inclusion 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 chemoradiation or perioperative chemoimmunotherapy and curative intent esophagectomy * 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 Exclusion Criteria: * Inability to provide Informed Consent * New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) * LFT\>3X upper limit of normal * Drug allergy to itraconazole * Positive pregnancy test * Those with QTc\>450 milliseconds (ms) will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant
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What it tests

  • Itraconazole
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Where

7 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, United States
Durham VA Medical Center, Durham, NC
Durham, United States
VA Portland Health Care System, Portland, OR
Portland, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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