MedTrace Logo

Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

NCT04018872 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-11-04

No results posted yet for this study

Summary

Esophageal cancer, which has a low 5-year overall survival rate for all stages (\<20%) , is increasing in incidence. Previous studies have shown that the Hedgehog (Hh) and AKT signaling pathways are activated in a significant proportion of esophageal cancers. Itraconazole, a widely used anti-fungal medication, has been shown to inhibit various pathways involved in esophageal cancer tumorigenesis including Hh and AKT. In this phase II clinical trial, the investigators aim to evaluate the effect of itraconazole as a neoadjuvant therapy following standard of care chemoradiation in the treatment of locoregional esophageal and gastroesophageal junction carcinomas.

Conditions

  • Esophagus Adenocarcinoma
  • Esophagus Squamous Cell Carcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Itraconazole

Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.

Sponsors & Collaborators

  • Dallas VA Medical Center

    lead FED

Principal Investigators

  • David Wang, MD, PhD · North Texas Veterans Healthcare System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2026-06-24
Completion
2026-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018872 on ClinicalTrials.gov