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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
At a glance
Conditions
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.
Study leadership
- David H Wang, MD PhD · PRINCIPAL_INVESTIGATOR · VA Ann Arbor Healthcare System, Ann Arbor, MI
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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.