NCT05563766 A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
| NCT ID | NCT05563766 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Esophageal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 78 participants in total. It began in 2024-10-01 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.
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
Contact & Investigator
David H Wang, MD PhD
✉ davidh.wang@va.govDavid H Wang, MD PhD
PRINCIPAL INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Frequently Asked Questions
Who can join the NCT05563766 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05563766 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05563766 currently recruiting?
Yes, NCT05563766 is actively recruiting participants. Contact the research team at davidh.wang@va.gov for enrollment information.
Where is the NCT05563766 trial being conducted?
This trial is being conducted at Palo Alto, United States, Ann Arbor, United States, Durham, United States, Portland, United States and 3 additional locations.
Who is sponsoring the NCT05563766 clinical trial?
NCT05563766 is sponsored by VA Office of Research and Development. The principal investigator is David H Wang, MD PhD at VA Ann Arbor Healthcare System, Ann Arbor, MI. The trial plans to enroll 78 participants.