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NCT04018872 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
A Phase 2 study of Gastroesophageal Junction Adenocarcinoma and Esophagus Adenocarcinoma, sponsored by Dallas VA Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT04018872: Recruiting Phase 2 study of Gastroesophageal Junction Adenocarcinoma and Esophagus Adenocarcinoma, sponsored by Dallas VA Medical Center.
NCT04018872 is a Phase 2 study of Gastroesophageal Junction Adenocarcinoma and Esophagus Adenocarcinoma that is actively recruiting participants, run by Dallas VA Medical Center. The registered enrollment target is 78 participants, below the 402-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04018872, a Phase 2 study of Gastroesophageal Junction Adenocarcinoma and Esophagus Adenocarcinoma, is actively recruiting participants, sponsored by Dallas VA Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Itraconazole
Study Locations (1)
Texas
- Dallas VA Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2026-09-29 |
| Phase | Phase 2 |
What NCT04018872 shows while recruiting
NCT04018872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 402-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Gastroesophageal Junction Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Itraconazole is the first listed.
NCT04018872 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04018872 about?
NCT04018872 is a clinical study titled "Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer". 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 ...
What is the current status of trial NCT04018872?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2019-06-24. Estimated completion is 2026-09-29.
What conditions does trial NCT04018872 study?
This clinical trial studies the following conditions: Gastroesophageal Junction Adenocarcinoma, Esophagus Adenocarcinoma, Esophagus Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04018872?
The interventions under investigation include: Itraconazole (DRUG).
Who is sponsoring clinical trial NCT04018872?
This trial is sponsored by Dallas VA Medical Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04018872 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04018872's enrollment target sits among peer trials
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