Esophageal Adenocarcinoma study: Itraconazole
Official title A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
ClinicalTrials.gov ID: NCT05563766
What this study is testing
What is Itraconazole?
An investigational oral medication being studied as a potential addition to standard chemoradiation for esophageal adenocarcinoma. is designed to inhibit Hedgehog, AKT, and VEGFR2 signaling pathways.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether giving itraconazole before surgery can increase the rate of complete tumor removal in patients with esophageal or gastro‑esophageal junction cancer.
- Who it's for
- It is looking for adults who have esophageal adenocarcinoma, esophageal squamous cell carcinoma, or gastro‑esophageal junction carcinoma and are scheduled for surgery.
- What's involved
- Participants will receive the usual chemotherapy and radiation, plus itraconazole, before their surgery. They will have regular clinic visits and tests to monitor the treatment.
- Time commitment
- The trial lasts about 6 to 8 months, including pre‑treatment visits, the chemo‑radiation period, surgery, and follow‑up appointments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of giving informed consent
- Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant...
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 at enrollment
- Adequate renal and liver function as judged by the treating physician
You likely can't join if
- Inability to provide Informed Consent
- New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
- LFT\>3X upper limit of normal
- Drug allergy to itraconazole
- Positive pregnancy test
- Those with QTc\>450 milliseconds (ms) will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating...
The study team makes the final eligibility decision.
Where it is enrolling
- Palo Alto, California, United States
- Ann Arbor, Michigan, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Palo Alto, California, United States; Ann Arbor, Michigan, United States; Durham, North Carolina, United States; Portland, Oregon, United States; Dallas, Texas, United States; Houston, Texas, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.