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The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

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ClinicalTrials.gov Identifier: NCT01475331
Recruitment Status : Completed
First Posted : November 21, 2011
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew T. Moyer, Milton S. Hershey Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Mucinous Pancreatic Cysts
Interventions: Drug: Ethanol
Drug: Normal Saline
Drug: Chemotherapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH

Chemotherapy: 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.

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(Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline

Chemotherapy: 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.


Participant Flow:   Overall Study
    Control Group   Study Group
STARTED   23   23 
COMPLETED   18   21 
NOT COMPLETED   5   2 
Osteophyte obstruction of the proximal                1                0 
excessive main duct communication                1                1 
Loss of needle positioning due pt. cough                1                0 
Sign of malignancy during the procedure                2                0 
cyst found to be prohibitively small                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group

Ethanol: Cysts will be lavaged for 3-5 minutes with 80% EtOH

Chemotherapy: 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.

Study Group

Normal Saline: Cysts will be lavaged for 3-5 minutes with normal saline

Chemotherapy: 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.

Total Total of all reporting groups

Baseline Measures
   Control Group   Study Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   21   39 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      4  22.2%      8  38.1%      12  30.8% 
>=65 years      14  77.8%      13  61.9%      27  69.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  72.2%      10  47.6%      23  59.0% 
Male      5  27.8%      11  52.4%      16  41.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   4.8%      1   2.6% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  11.1%      1   4.8%      3   7.7% 
White      16  88.9%      19  90.5%      35  89.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   18   21   39 


  Outcome Measures

1.  Primary:   Number of Participants With the Changing in Cyst Volume   [ Time Frame: 6, and 12 months post procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Because of small number of participants this single-center trial is still weakly powered to show these differences with high levels of scientific certainty.Study was limited to one ablation only.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Matthew T. Moyer
Organization: Milton S. Hershey Medical Center
phone: 717-531-3694
e-mail: mmoyer@pennstatehealth.psu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Matthew T. Moyer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01475331     History of Changes
Other Study ID Numbers: IRB 33751
First Submitted: November 8, 2011
First Posted: November 21, 2011
Results First Submitted: January 5, 2018
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018