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Recruiting
NCT05563766
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Conditions: Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Junction Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 78
Sponsor: VA Office of Research and Development
Location: VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California
Summary
Esophageal cancer, which has a low 5-year overall survival rate (\
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05563766). StuddyBuddy aggregates publicly available trial information.
