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Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celsion
ClinicalTrials.gov Identifier:
NCT00617981
First received: February 6, 2008
Last updated: March 24, 2017
Last verified: March 2017
History of Changes
Results First Received: February 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Interventions: Drug: ThermoDox
Drug: 5% Dextrose Solution

  Participant Flow
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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
ThermoDox + RFA

ThermoDox should be administered at 50 mg/m2. The infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.

ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
Sham + RFA

Sham infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.

5% Dextrose Solution: Single 30 minute intravenous infusion

Participant Flow:   Overall Study
    ThermoDox + RFA   Sham + RFA
STARTED   354   347 
COMPLETED   244   245 
NOT COMPLETED   110   102 



  Baseline Characteristics
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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
ThermoDox + RFA

ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.

ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
Sham + RFA

Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.

5% Dextrose Solution: Single 30 minute intravenous infusion
Total Total of all reporting groups

Baseline Measures
   ThermoDox + RFA   Sham + RFA   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 354   347   701 
Age, Customized 
[Units: Participants]
 		     
<40   7   10   17 
40-<45   13   14   27 
45-<50   18   25   43 
50-<55   42   44   86 
55-<60   57   50   107 
60-<65   65   64   129 
65-<70   44   45   89 
70-<75   51   42   93 
75-<80   33   34   67 
80-<85   19   13   32 
85+   2   4   6 
Missing   3   2   5 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      87  24.6%      84  24.2%      171  24.4% 
Male      267  75.4%      263  75.8%      530  75.6% 
Race/Ethnicity, Customized 
[Units: Participants]
 		     
Caucasian   42   26   68 
Japanese   8   11   19 
Korean   83   91   174 
Taiwanese   66   62   128 
Chinese   115   125   240 
Other   40   32   72 
Region of Enrollment 
[Units: Participants]
 		     
United States   10   5   15 
Philippines   18   21   39 
Taiwan   68   63   131 
Hong Kong   6   9   15 
Canada   5   10   15 
Thailand   16   8   24 
Malaysia   7   6   13 
Japan   8   10   18 
Italy   32   17   49 
China   104   104   208 
Korea, Republic of   82   92   174 


  Outcome Measures

1.  Primary:   Progression Free Survival Will be Measured From the Date of Randomization to the First Date on Which One of the Following Occurs. o Local Recurrence o Any New Distant Intrahepatic HCC Tumor o Any New Extrahepatic HCC Tumor o Death From Any Cause   [ Time Frame: 3 years ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival as Measured by Time From Randomization to Death or the End of the Study.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Time to Definite Worsening as Per Patient-Reported Outcomes   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Time to Local Recurrence.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Safety   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nicholas Borys, M.D. Senior Vice President and Chief Medical Officer
Organization: Celsion Corporation
phone: 609-896-9100
e-mail: nborys@celsion.com



Responsible Party: Celsion
ClinicalTrials.gov Identifier: NCT00617981     History of Changes
Other Study ID Numbers: 104-06-301
Study First Received: February 6, 2008
Results First Received: February 3, 2017
Last Updated: March 24, 2017