NCT05563766RecruitingPhase 2
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 27 Sept 2022
- Start date
- 1 Oct 2024
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05563766
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 78
- From 1 Oct 2024 to the primary completion date, 30 Apr 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
- Drug allergy to itraconazole
Lab values
- 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
Other
- Inability to provide Informed Consent
- LFT\>3X upper limit of normal
- Positive pregnancy test
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Durham VA Medical Center, Durham, NC Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Michael E. DeBakey VA Medical Center, Houston, TX Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| VA Palo Alto Health Care System, Palo Alto, CA Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| VA Portland Health Care System, Portland, OR Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.