Chemotherapy + Alcohol Ablation for Pancreatic Cysts
(CHARM Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMatthew T. Moyer, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Milton S. Hershey Medical Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Matthew T. Moyer, MD, MS

Principal Investigator

Penn State Health Milton S Hershey Medical Center

Eligibility Criteria

Adults over 18 with a pancreatic cyst 2-5 cm in size, likely mucinous based on ASGE guidelines. Participants must be able to undergo endoscopy with sedation or anesthesia and provide consent. Excluded are those with benign cysts, suspected cancer, certain high-risk cyst features, recent pancreatitis, abnormal lab values (like blood cell counts and liver enzymes), severe medical conditions affecting life expectancy under five years, pregnant or breastfeeding women.

Inclusion Criteria

I am over 18 years old.

I can safely undergo procedures with deep sleep or general anesthesia.

I have a pancreatic cyst between 2-5 cm, likely mucinous.

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Exclusion Criteria

My pancreatic cyst has features that may suggest a higher risk of cancer.

Baseline lab values (must be within 6 months of consent date) outside specified ranges

I was diagnosed with acute pancreatitis in the last 6 months.

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Treatment Details

Interventions

Ethanol (Alkylating agents)
Normal saline (Other)
Paclitaxel + Gemcitabine admixture (Anti-tumor antibiotic, Anti-metabolites)

Trial OverviewThe trial is testing the effectiveness of using ethanol lavage followed by paclitaxel + gemcitabine infusion versus saline lavage plus the same chemotherapy cocktail for treating pancreatic cystic neoplasms. The treatments are delivered through an endoscopic ultrasound-guided needle.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Study groupExperimental Treatment2 Interventions

Cyst will be lavaged for 3 to 5 minutes with normal saline. Following lavage with normal saline, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).

Group II: Control GroupActive Control2 Interventions

Cyst will be lavaged for 3 to 5 minutes with \>/=99% ethanol. Following lavage with \>/=99% ethanol, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).