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NCT05634720 · ClinicalTrials.gov registry record · Phase 4
Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
A Phase 4 study of Pancreatic Ductal Adenocarcinoma, sponsored by Duke University.
- Active
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05634720 is a Phase 4 study of Pancreatic Ductal Adenocarcinoma that is active but no longer recruiting, run by Duke University. The registered enrollment target is 20 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05634720, a Phase 4 study of Pancreatic Ductal Adenocarcinoma, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy. Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes. The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and overall survival (OS).
Conditions Studied
Interventions
- DRUG HA Chemotherapy
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-01-02 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05634720
The ClinicalTrials.gov registry entry for NCT05634720 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (97% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which HA Chemotherapy is the first listed.
NCT05634720 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05634720 about?
NCT05634720 is a clinical study titled "Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer". This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy. Current s...
What is the current status of trial NCT05634720?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-01-02. Estimated completion is 2028-12-31.
What conditions does trial NCT05634720 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT05634720?
The interventions under investigation include: HA Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT05634720?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05634720 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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