Endoscopic Ultrasound-Guided Chemoablation for Pancreatic Cysts
(ERASE-Chemo Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. Pancreatic cysts are a common precancerous lesion that may develop into pancreatic cancer. An EUS is a procedure in which an endoscope is inserted into the body. An endoscope is a thin, tube-like instrument that has a light and a lens for viewing. A probe at the end of the endoscope is used to bounce high-energy sound waves (ultrasound) off internal organs to make a picture (sonogram). EUS-guided chemoablation uses a fine needle inserted into the pancreatic cyst to deliver chemotherapy, such as gemcitabine and paclitaxel, directly into the cyst ("intracystic"). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. An EUS-guided chemoablation, with gemcitabine and paclitaxel, may be an effective minimally invasive strategy to destroy abnormal or precancerous cells while reducing exposure to the rest of the body in patients with pancreatic cysts.
Who Is on the Research Team?
Somashekar G Krishna, MD, MPH
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo EUS-guided fine needle aspiration and chemoablation with gemcitabine and paclitaxel via intracystic fine needle injection on day 0
Follow-up
Participants are monitored for safety and effectiveness after treatment, with imaging and possible EUS with or without FNA as clinically indicated
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine Hydrochloride
- Paclitaxel
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
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