Chemotherapy + Alcohol Ablation for Pancreatic Cysts
(CHARM Trial)
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for pancreatic cysts?
Research shows that using a combination of alcohol and paclitaxel for treating pancreatic cysts can lead to complete cyst resolution in about 72% of patients, with most remaining cyst-free for years. However, there are some risks of complications, and the treatment's long-term impact on preventing pancreatic cancer is still unclear.12345
Is the combination of chemotherapy drugs nab-paclitaxel and gemcitabine safe for treating pancreatic cancer?
How is the chemotherapy and alcohol ablation treatment for pancreatic cysts different from other treatments?
This treatment is unique because it combines chemotherapy drugs, Paclitaxel and Gemcitabine, with alcohol ablation, which is a method that uses alcohol to destroy tissue. This combination aims to enhance the effectiveness of chemotherapy by directly targeting pancreatic cysts, potentially offering a more focused approach compared to traditional systemic chemotherapy.7891011
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo EUS-FNI procedure with either ethanol or saline lavage followed by infusion of paclitaxel and gemcitabine
Initial Follow-up
Participants are contacted by phone at 72 hours and 30 days post-procedure to assess adverse events
3-Month Follow-up
Participants undergo a follow-up EUS examination to assess cyst response and possible repeat ablation
Long-term Follow-up
Participants undergo MRI-MRCP or CT scan at 12 and 24 months to assess treatment response
Treatment Details
Interventions
- Ethanol
- Normal saline
- Paclitaxel + Gemcitabine admixture
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator