Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT05563766
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 and curative intent esophagectomy
* World Health Organization (WHO)/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
* NYHA class III or IV CHF
* LFT\>3X upper limit of normal
* Drug allergy to itraconazole
* Positive pregnancy test
* Those with QTc\>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05563766
Study Brief:
Protocol Section:
NCT05563766