drugset / Trial / NCT03085004
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
Phase 3
Terminated
75 enrolled
Milton S. Hershey Medical Center
National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2019-04-12
- Primary completion
- 2025-12-31
- Completion
- 2026-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alcohol | Other / unclassified | — | Other |
| Background | Gemcitabine | Small molecule | 19 mg/ml | Other |
| Background | Paclitaxel | Small molecule | 3 mg/ml | Other |