Itraconazole for Resectable Esophageal Cancer

This study is looking at whether adding a common antifungal medicine called itraconazole can improve treatment for esophageal cancer. Esophageal cancer is becoming more common, and current treatments don't always work well. Previous research suggests that itraconazole might help by blocking certain pathways (Hedgehog, AKT, and angiogenic signaling) that are active in esophageal cancer cells and help them grow. In this study, 78 patients with resectable esophageal or gastroesophageal junction cancer will receive itraconazole along with their usual treatment of chemotherapy, radiation, and surgery. The main goal is to see if itraconazole increases the rate of a "pathological complete response" (meaning no cancer cells are found after treatment). You may be able to join if you are 18 or older, have resectable esophageal or GEJ cancer, and are planning to have standard chemoradiation and surgery.

Study design
This is a Phase II interventional study aiming to enroll 78 participants. It is not specified if it is randomized or blinded.
What's involved
You would take oral itraconazole for two weeks before starting standard chemoradiation, and then for 6-8 weeks after finishing chemoradiation. You would also have standard staging tests and follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, pathological complete response, is measured at 20 weeks after treatment.

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NCT05563766

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
VA Office of Research and Development
~78 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:Itraconazole

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of pathological complete response with itraconazole
Measured over 20 weeks
Esophageal Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Gastroesophageal Junction Carcinoma

NCT05563766

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texasstudy coordinator listed

    Recruiting

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

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

    Dallas, Texasstudy coordinator listed

    Recruiting

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

    Palo Alto, Californiastudy coordinator listed

    Recruiting

  • VA Portland Health Care System, Portland, OR

    Portland, Oregonstudy coordinator listed

    Recruiting

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

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • David H Wang, MD PhD · PRINCIPAL_INVESTIGATOR · VA Ann Arbor Healthcare System, Ann Arbor, MI

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Eligibility criteria

Inclusion

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

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
  • Rate of pathological complete response with itraconazole20 weeks

    Historically, the pathCR rate at time of esophagectomy is 25%. The investigators have powered our study to detect a 15% or more improvement in pathCR rate following treatment with itraconazole. By inhibiting pathways that mediate chemoradiation resistance, the investigators anticipate an improved pathCR rate.