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NCT05563766 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
A Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 7
- Study locations
NCT05563766: Recruiting Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma, sponsored by VA Office of Research and Development.
NCT05563766 is a Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 78 participants, below the 307-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (75% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05563766, a Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 7
- Study locations
Study Summary
Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Itraconazole
Study Locations (7)
Texas
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX - Dallas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
California
- VA Palo Alto Health Care System, Palo Alto, CA - Palo Alto
Michigan
- VA Ann Arbor Healthcare System, Ann Arbor, MI - Ann Arbor
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Oregon
- VA Portland Health Care System, Portland, OR - Portland
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2029-06-15 |
| Phase | Phase 2 |
What NCT05563766 shows while recruiting
NCT05563766 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 307-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (75% lower).
The record links to 3 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Itraconazole is the first listed.
NCT05563766 lists 7 locations in 6 states (Texas, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT05563766 about?
NCT05563766 is a clinical study titled "A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer". Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effec...
What is the current status of trial NCT05563766?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2024-10-01. Estimated completion is 2029-06-15.
What conditions does trial NCT05563766 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Junction Carcinoma.
What interventions are being tested in trial NCT05563766?
The interventions under investigation include: Itraconazole (DRUG).
Who is sponsoring clinical trial NCT05563766?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05563766 being conducted?
This trial has 7 study locations across California, Michigan, North Carolina, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05563766's enrollment target sits among peer trials
78 20th of 43 higher than 23 of 43 other Esophageal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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