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Anti-tumor antibiotic, Anti-metabolites
Chemotherapy + Alcohol Ablation for Pancreatic Cysts (CHARM Trial)
Phase 3
Waitlist Available
Led By Matthew T. Moyer, MD, MS
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capable of safely undergoing endoscopy with deep sedation or general anesthesia
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts
Must not have
Cysts with high-risk features such as main pancreatic duct dilation of > 5mm, epithelial type mural nodules (> 2mm), pathologically thick wall/septation (> 2mm), cytology showing high grade dysplasia or 'suspicious for malignancy', signs of common bile duct or pancreatic duct obstruction, solid mass component within or associated with the cyst (> 2mm), pancreatic duct stricture associated with tail atrophy, or previous fine needle aspiration failure due to excessive cyst fluid viscosity
Confirmed acute pancreatitis within the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post initial treatment
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will compare the effect of adding chemotherapeutic drugs to alcohol used to clean out pancreatic cysts versus just using the drugs by themselves.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects include irritation from ethanol lavage; reactions to chemotherapy like nausea, fatigue, hair loss; possible infection risk due to needle insertion; and complications from endoscopy such as bleeding or perforation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can safely undergo procedures with deep sleep or general anesthesia.
Select...
I have a pancreatic cyst between 2-5 cm, likely mucinous.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My pancreatic cyst has features that may suggest a higher risk of cancer.
Select...
I was diagnosed with acute pancreatitis in the last 6 months.
Select...
I have or might have pancreatic cancer or abnormal lymph nodes.
Select...
My lesion is confirmed as benign following various tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post initial treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post initial treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of serious and minor adverse events occurring within 30 days post ablation
Percentage of subjects achieving complete cyst resolution at 12 months
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Normal saline
2013
Completed Phase 4
~2090
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,837 Total Patients Enrolled
7 Trials studying Pancreatic Cyst
13,341 Patients Enrolled for Pancreatic Cyst
Milton S. Hershey Medical CenterLead Sponsor
508 Previous Clinical Trials
2,796,244 Total Patients Enrolled
1 Trials studying Pancreatic Cyst
46 Patients Enrolled for Pancreatic Cyst
Matthew T. Moyer, MD, MS5.03 ReviewsPrincipal Investigator - Penn State Health Milton S Hershey Medical Center
Milton S. Hershey Medical Center
5Patient Review
I sought out Dr. Moyer for a second opinion after my original colonoscopy revealed a mass. The treating surgeon wanted to do a right hemicolectomy, but Dr. Moyer was able to remove 90% of the mass during a subsequent colonoscopy. The mass was non-cancerous, as confirmed by pathology. I'm very grateful to Dr. Moyer for his expertise and willingness to help me. I would highly recommend him to anyone in a similar situation.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pancreatic cyst has features that may suggest a higher risk of cancer.I was diagnosed with acute pancreatitis in the last 6 months.I am over 18 years old.I can safely undergo procedures with deep sleep or general anesthesia.I have or might have pancreatic cancer or abnormal lymph nodes.My lesion is confirmed as benign following various tests.I have a pancreatic cyst between 2-5 cm, likely mucinous.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Study group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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