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NCT03085004 · ClinicalTrials.gov registry record · Phase 3
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
A Phase 3 study of Pancreatic Cyst and EUS-FNA, sponsored by Milton S. Hershey Medical Center.
- Active
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 2
- Study locations
NCT03085004: Active Phase 3 study of Pancreatic Cyst and EUS-FNA, sponsored by Milton S. Hershey Medical Center.
NCT03085004 is a Phase 3 study of Pancreatic Cyst and EUS-FNA that is active but no longer recruiting, run by Milton S. Hershey Medical Center. The registered enrollment target is 75 participants, below the 546-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03085004, a Phase 3 study of Pancreatic Cyst and EUS-FNA, is active but no longer recruiting, sponsored by Milton S. Hershey Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound guided fine needle infusion (EUS-FNI) for agent delivery.
Primary Outcome
This is defined as Complete response greater than or equal to 95% reduction in cyst volume and measured by "r" as cyst volume 4/3×π×r3 at 12 months post initial treatment
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG Ethanol
- DRUG Paclitaxel + Gemcitabine admixture
Study Locations (2)
Indiana
- Indiana University Health University Hospital - Indianapolis
Pennsylvania
- Penn State Health Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-04-12 |
| Est. Completion | 2026-02-01 |
| Phase | Phase 3 |
What the registry record for NCT03085004 still lists
NCT03085004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 546-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Pancreatic Cyst appearing as the primary indexed condition, and to 3 interventions - of which Normal saline is the first listed.
NCT03085004 reports a single indexed study location in Indiana, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03085004 about?
NCT03085004 is a clinical study titled "CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts". The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same d...
What is the current status of trial NCT03085004?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2019-04-12. Estimated completion is 2026-02-01.
What conditions does trial NCT03085004 study?
This clinical trial studies the following conditions: Pancreatic Cyst, EUS-FNA.
What interventions are being tested in trial NCT03085004?
The interventions under investigation include: Normal saline (DRUG), Ethanol (DRUG), Paclitaxel + Gemcitabine admixture (DRUG).
Who is sponsoring clinical trial NCT03085004?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03085004 being conducted?
This trial has 2 study locations across Indiana, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pancreatic Cyst
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 NCT03085004's enrollment target sits among peer trials
75 13th of 18 higher than 6 of 18 other Pancreatic Cyst trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cyst 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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