Phase II Study of Itraconazole Added to Chemoradiation and Surgery for Treating Resectable Esophageal and Gastroesophageal Junction Cancers

What this Trial Is About

Esophageal cancer, including esophageal adenocarcinoma, squamous cell carcinoma, and gastroesophageal junction carcinoma, has a low five-year survival rate under 20% and is becoming more common. Researchers are studying whether adding itraconazole, an antifungal medication that blocks certain cancer growth pathways, to the usual treatment of chemoradiation and surgery can improve outcomes. This phase II trial aims to see if itraconazole increases the rate of complete tumor disappearance after treatment in patients with resectable esophageal or gastroesophageal junction cancer. Patients will first have standard cancer staging with PETCT scans and endoscopic ultrasound to check for spread. If no distant cancer is found, they will take oral itraconazole twice daily for two weeks before starting standard neoadjuvant chemoradiation. After completing chemoradiation, patients will continue itraconazole for 6 to 8 weeks. Following treatment, if scans show no new metastases, patients will undergo surgery to remove the esophagus. Throughout the study, itraconazole levels and side effects will be monitored to assess adherence and safety. Participants will have tissue samples collected before and after treatment to analyze the activity of cancer growth pathways and measure drug levels. Blood samples will also be tested for circulating tumor DNA and exosomes as markers of response. The main outcome is the rate of pathologic complete response at about 20 weeks. Secondary goals include correlating drug levels with outcomes and developing genetic profiles to predict treatment response. This study lasts from initial staging through surgery and follow-up assessments.

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