ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Study Group
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 23 23
Completed 18 21
Not Completed 5 2
Reason Not Completed
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
Arm/Group Title Control Group Study Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 18 21 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
Female
13
  72.2%
10
  47.6%
23
  59.0%
Male
5
  27.8%
11
  52.4%
16
  41.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 21 participants 39 participants
18
 100.0%
21
 100.0%
39
 100.0%
1.Primary Outcome
Title Number of Participants With the Changing in Cyst Volume
Hide Description 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.
Time Frame 6, and 12 months post procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (all participants at least one dose of intervention)
Arm/Group Title Control Group Study Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 21
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response after 6 mon
6
  33.3%
12
  57.1%
Partial Response after 6 months
5
  27.8%
4
  19.0%
No Response after 6 months
6
  33.3%
5
  23.8%
Complete Response after 12 months
11
  61.1%
14
  66.7%
Partial Response after 12 months
4
  22.2%
3
  14.3%
No Response after 12 months
3
  16.7%
4
  19.0%
Time Frame Adverse events were determined and collected through study completion, an average of 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Study Group
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Control Group Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Study Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/21 (0.00%)    
Gastrointestinal disorders     
acute pancreatitis  [1]  1/18 (5.56%)  1 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
acute pancreatitis after ablation of 20-mm tail cyst requiring a 36- hour hospital stay
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Group Study Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/18 (22.22%)      0/21 (0.00%)    
Gastrointestinal disorders     
abdominal pain  [1]  4/18 (22.22%)  4 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
abdominal pain requiring unscheduled clinical evaluation and treatment for pain control
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.
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
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