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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

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.Check my eligibility
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.See study design
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 below
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I can safely undergo procedures with deep sleep or general anesthesia.
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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:
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My pancreatic cyst has features that may suggest a higher risk of cancer.
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I was diagnosed with acute pancreatitis in the last 6 months.
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I have or might have pancreatic cancer or abnormal lymph nodes.
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My lesion is confirmed as benign following various tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post initial treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post initial treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of serious and minor adverse events occurring within 30 days post ablation
Percentage of subjects achieving complete cyst resolution at 12 months

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
13,748 Previous Clinical Trials
40,959,301 Total Patients Enrolled
7 Trials studying Pancreatic Cyst
13,341 Patients Enrolled for Pancreatic Cyst
Milton S. Hershey Medical CenterLead Sponsor
500 Previous Clinical Trials
2,801,517 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

Paclitaxel + Gemcitabine admixture (Anti-tumor antibiotic, Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03085004 — Phase 3
Pancreatic Cyst Research Study Groups: Control Group, Study group
Pancreatic Cyst Clinical Trial 2023: Paclitaxel + Gemcitabine admixture Highlights & Side Effects. Trial Name: NCT03085004 — Phase 3
Paclitaxel + Gemcitabine admixture (Anti-tumor antibiotic, Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03085004 — Phase 3
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