- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475331
The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
While about half of pancreatic cystic lesions have little to no malignant potential, mucinous cystic neoplasms (MCNs) and intraductal papillary mucinous neoplasms (IPMNs) carry a high potential for progression into pancreatic cancer. Therefore, either close radiographic surveillance or surgical resection is generally recommended for these cysts. However, pancreatic surgery is associated with a significant risk of morbidity and mortality and not all patients are good surgical candidates. As an alternative, endoscopic ultrasound-guided fine needle injection(EUS-FNI) has been shown to be moderately effective in ablating cystic lesions.
The goal of this investigation is to improve the efficacy and safety of this procedure when compared with previous versions of the technique. This study is designed to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of pancreatic cystic neoplasms using EUS-FNI for agent delivery. This paired, prospective, double-blind, randomized study will include 78 patients referred to the Penn State Hershey Medical Center. Mucinous or indeterminate pancreatic cysts of 1-5cm with less than 5 compartments and without clear communication with the main pancreatic duct will be included. Patients will be randomized in a 1:1 ratio into a control arm or study arm. Patients randomized to the control arm will receive ethanol lavage of the cyst followed by injection of two carefully selected chemotherapeutic agents. Study arm patients will receive a normal saline lavage followed by injection of the same chemotherapy admixture. Patients will be monitored for 2 hours post-procedure, and a follow-up CT will be performed at 6, and 12 months, or as determined necessary to evaluate cyst resolution. Patients may elect to undergo evaluation for surgical resection at any time, regardless of response, in which case a dedicated pathologist will evaluate any surgical specimens.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients age 18 and older of any gender, ethnicity and race
- Voluntary enrollment and ability to give written informed consent
- Capable of safely undergoing endoscopy with deep sedation or general anesthesia
- Patients with previously-detected pancreatic cyst(s) 1-5 cm in diameter, including indeterminate cysts
Exclusion Criteria:
- Pancreatic cyst <1cm or >5cm
- Pancreatic cyst with clear communication with main pancreatic duct
- Clearly benign lesions by clinical and radiographic evaluation (pseudocysts and serous cystadenomas)
- Known or suspected pancreatic cancer or pathologic lymphadenopathy
- Septated cysts with > 5 compartments
- Coagulopathy (international normalized ratio > 1.6, platelets < 30,000)
- Evidence of active pancreatitis or pancreatic infection
- Patients having undergone endoscopic retrograde cholangiopancreatography (ERCP) within 72 hours
- Baseline lab values at the time of consent: white blood cells > 14 or < 2, hematocrit < 30, platelets < 30,000, INR > 1.6, abnormal CA19-9, lipase > 3 times the upper limit of normal, creatinine > 2.5, ALT > 210, total bilirubin > 2.5, positive qualitative beta-hCG.
- Any pre-existing or discovered medical condition that may, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol.
- Pregnant, breastfeeding, or incarcerated individuals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%).
Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.
|
Cysts will be lavaged for 3-5 minutes with 80% EtOH
Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.
|
Experimental: Study Group
Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.
|
Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.
Cysts will be lavaged for 3-5 minutes with normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With the Changing in Cyst Volume
Time Frame: 6, and 12 months post procedure
|
The primary outcome of interest will be change in cyst size, as measured on initial, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution.
Cyst size was calculated by measuring x and y diameters and calculating cyst volume using the formula:4/3xpxr3 where r is the average of the cyst radius as measured on the initial, 6-month, and 12-month magnetic resonance imaging or computed tomography.
Response was defined according to the same volume percentage reductions as described in previous trials where: complete response is a =>95% reduction in cyst volume, partial response is a 94%-75% reduction, and anon-response is <75% reduction in volume.11
The overall ablation rates in both arms were also compared with historical controls to assess the efficacy of the chemotherapeutic cocktail.
|
6, and 12 months post procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 33751
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mucinous Pancreatic Cysts
-
University of NebraskaNot yet recruitingPancreatic Cyst | Pancreatic Mucinous Cystic NeoplasmUnited States
-
Johns Hopkins UniversityLustgarten FoundationRecruitingPancreatic Mucinous-Cystic Neoplasm | Pancreatic Cysts | Intraductal Papillary Mucinous Neoplasm | Solid Pseudopapillary Tumour of the Pancreas | Cystic, Mucinous and/or Serous NeoplasmUnited States
-
Herlev HospitalRigshospitalet, DenmarkCompletedPancreatic Adenocarcinoma | Pancreatic Cyst | IPMN | Mucinous CystDenmark
-
Seoul National University HospitalCompletedIntraductal Papillary Mucinous Neoplasm | Pancreas CystKorea, Republic of
-
University of California, San FranciscoRecruitingPancreatic Neoplasms | Pancreatic Cancer | Pancreatic Diseases | Pancreatic Ductal Adenocarcinoma | Pancreatic Cyst | Intraductal Papillary Mucinous Neoplasm | Mucinous Cyst | Pancreatic Intraductal Papillary Mucinous NeoplasmUnited States
-
Samsung Medical CenterUnknownPancreatic Mucinous-Cystic NeoplasmKorea, Republic of
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI); University of Miami; University of FloridaRecruitingPancreatic Cancer | Pancreatic CystUnited States
-
Hospital St. Joseph, Marseille, FranceRamsay Générale de SantéActive, not recruitingPancreatic Cyst | IPMN | Pancreas Cyst | Serous Cystadenoma | Mucinous CystadenomaFrance
-
University of Medicine and Pharmacy CraiovaM.D. Anderson Cancer Center; Massachusetts General Hospital; University College... and other collaboratorsTerminatedCystadenocarcinoma | Pancreatic Mucinous-Cystic Neoplasm | Pancreatic Cysts | Intraductal Papillary Mucinous Neoplasm | Solid Pseudopapillary Tumour of the Pancreas | Serous CystadenomaUnited States, Denmark, Romania, United Kingdom
-
Indiana UniversityCompletedPancreatic Cyst | Pancreatic Intraductal Papillary-Mucinous Neoplasm | Cystadenoma, Mucinous | Papillary Mucinous Cystadenoma, Borderline MalignancyUnited States
Clinical Trials on Ethanol
-
Parc de Salut MarCompletedHealthy | Alcohol ConsumptionSpain
-
Virginia Commonwealth UniversityU.S. Department of JusticeRecruitingElectronic Cigarette UseUnited States
-
Yale UniversityVA Connecticut Healthcare SystemCompleted
-
Beth Israel Deaconess Medical CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Virginia Commonwealth UniversityU.S. Department of JusticeCompleted
-
Merck Sharp & Dohme LLCCompleted
-
University of NebraskaWithdrawnShort Bowel Syndrome | Blood Stream InfectionsUnited States
-
National Institute of Diabetes and Digestive and...CompletedType 2 Diabetes, Insulin RequiringUnited States
-
Indonesia UniversityNetherlands: Ministry of Health, Welfare and SportsCompleted
-
OrfagenFDA Office of Orphan Products DevelopmentCompletedCongenital Venous MalformationUnited States, France