Itraconazole for Esophageal and Gastroesophageal Junction Cancer
This study is looking at whether adding itraconazole, an antifungal medication, can improve treatment for localized esophageal cancer and gastroesophageal junction (GEJ) cancer. Researchers believe itraconazole may work by blocking certain pathways (Hedgehog and AKT) that help cancer grow. You might be able to join if you have localized esophageal or GEJ cancer and are at least 18 years old. The study aims to see if itraconazole increases the percentage of patients who have a "pathological complete response" (meaning no cancer cells are found after treatment) when measured 3-4 months after starting itraconazole. The study is currently recruiting about 78 participants.
- Study design
- This is an interventional study involving approximately 78 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive standard chemoradiation, followed by taking itraconazole by mouth twice daily for 6-8 weeks, and then undergo surgery. You would also have monitoring for side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 3-4 months after starting itraconazole, which is when the surgery would typically occur.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
At a glance
Conditions
NCT04018872
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Dallas VA Medical Center
Dallas, Texasstudy 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.
Study leadership
- David Wang, MD, PhD · PRINCIPAL_INVESTIGATOR · North Texas Veterans Healthcare System
Who to contact
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Inclusion
Exclusion
What this trial measures
- Percentage of pathological complete response with itraconazole3-4 months
Generally for esophageal cancer the pathological complete response rate at time of esophagectomy is 25%, and we have designed our study with the projected number of patients assuming we observe an improvement of 15% or more in this rate following treatment with itraconazole. This is the study's primary endpoint. By inhibiting the Hh signaling pathway with the use of itraconazole, we anticipate improved pathological complete response rates.