CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

April 12, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

February 1, 2026

Conditions
Pancreatic CystEUS-FNA
Interventions
DRUG

Ethanol

The cyst will be lavaged for 3 to 5 minutes using \>/=99% ethanol as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

DRUG

Normal saline

The cyst will be lavaged for 3 to 5 minutes using normal saline as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

DRUG

Paclitaxel + Gemcitabine admixture

Following lavage, cysts will be infused with an admixture of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Trial Locations (2)

17033

Penn State Health Milton S. Hershey Medical Center, Hershey

46202

Indiana University Health University Hospital, Indianapolis

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Milton S. Hershey Medical Center

OTHER