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NCT05825066 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
A Phase 2 study of Locally Advanced Pancreatic Adenocarcinoma and Pancreas Adenocarcinoma, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT05825066: Recruiting Phase 2 study of Locally Advanced Pancreatic Adenocarcinoma and Pancreas Adenocarcinoma, sponsored by Wake Forest University Health Sciences.
NCT05825066 is a Phase 2 study of Locally Advanced Pancreatic Adenocarcinoma and Pancreas Adenocarcinoma that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 64 participants, roughly in line with the 64-participant average among 18 other Locally Advanced Pancreatic Adenocarcinoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05825066, a Phase 2 study of Locally Advanced Pancreatic Adenocarcinoma and Pancreas Adenocarcinoma, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.
Primary Outcome
The R0 resection is assessed only in patients who undergo surgery. R0 resection is a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. Participants are considered to be evaluable if they receive at least one sequence of treatments with GA and mFFX (1 cycle GA followed by 1 cycle of m FFX). Primary analysis for each cohort will calculate the R0 resection rate with one-sided 95% confidence interval.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG mFOLFIRINOX
- DRUG Nab paclitaxel
- OTHER Radiological Assessments
Study Locations (1)
North Carolina
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2029-07 |
| Phase | Phase 2 |
What NCT05825066 shows while recruiting
NCT05825066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 64-participant average among 18 other Locally Advanced Pancreatic Adenocarcinoma trials with a reported enrollment target.
The record links to 3 conditions, with Locally Advanced Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Gemcitabine is the first listed.
NCT05825066 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05825066 about?
NCT05825066 is a clinical study titled "Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma". The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINO...
What is the current status of trial NCT05825066?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2023-08-01. Estimated completion is 2029-07.
What conditions does trial NCT05825066 study?
This clinical trial studies the following conditions: Locally Advanced Pancreatic Adenocarcinoma, Pancreas Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT05825066?
The interventions under investigation include: Gemcitabine (DRUG), mFOLFIRINOX (DRUG), Nab paclitaxel (DRUG), Radiological Assessments (OTHER).
Who is sponsoring clinical trial NCT05825066?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05825066 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Locally Advanced Pancreatic Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05825066's enrollment target sits among peer trials
64 5th of 18 higher than 14 of 18 other Locally Advanced Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Locally Advanced Pancreatic 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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