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NCT05709574 · ClinicalTrials.gov registry record · Phase 2
Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer
A Phase 2 study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05709574: Recruiting Phase 2 study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by University of Arizona.
NCT05709574 is a Phase 2 study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 10 participants, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05709574, a Phase 2 study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to assess the ability of Tadalafil alone and in combination with neoadjuvant FLOT (5-Fluorouracil, Oxaliplatin, and Docetaxel) chemotherapy to suppress myeloid derived suppressor cells (MDSCs) in patients with resectable gastric or gastroesophageal junction adenocarcinoma. Resectable means the tumor may be removed through surgical intervention. Neoadjuvant chemotherapy is chemotherapy received before the primary course of treatment i.e.surgical intervention. The main questions it aims to answer are: * Is Tadalafil treatment with FLOT feasible and safe? * How does tadalafil treatment with FLOT affect the tumor microenvironment (TME)? * Will 8 weeks of neoadjuvant exposure to tadalafil with chemotherapy reduce MDSCs in the TME? Participants will receive Tadalafil for 14 days followed by combination of Tadalafil + FLOT for approximately 8 weeks as a part of standard of care neoadjuvant treatment in the window between cancer diagnosis and surgical intervention to remove their tumor. Tumor tissue, blood, and urine will be collected at the start of the study, after 2 weeks of treatment with Tadalafil alone, and around the time of surgical intervention. Saliva will also be collected at the start of the study.
Primary Outcome
To evaluate the safety and tolerability by assessing the number of participants with treatment related adverse events using CTCAE v5.0.
Conditions Studied
Interventions
- DRUG Tadalafil 20 MG
Study Locations (1)
Arizona
- Arizona Cancer Center at UMC North/University Medical Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-04-20 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
What NCT05709574 shows while recruiting
NCT05709574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Tadalafil 20 MG is the first listed.
NCT05709574 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT05709574 about?
NCT05709574 is a clinical study titled "Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer". The goal of this clinical trial is to assess the ability of Tadalafil alone and in combination with neoadjuvant FLOT (5-Fluorouracil, Oxaliplatin, and Docetaxel) chemotherapy to suppress myeloid derived suppressor cells (MDSCs) in patients with resectable gastric or gastroesophageal junction adenoca...
What is the current status of trial NCT05709574?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2023-04-20. Estimated completion is 2026-05-31.
What conditions does trial NCT05709574 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma.
What interventions are being tested in trial NCT05709574?
The interventions under investigation include: Tadalafil 20 MG (DRUG).
Who is sponsoring clinical trial NCT05709574?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05709574 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05709574's enrollment target sits among peer trials
10 48th of 47 the lowest of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric 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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