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Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614913
First Posted: February 13, 2008
Last Update Posted: August 20, 2012
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.
Information provided by (Responsible Party):
David Bush, Loma Linda University
Results First Submitted: June 29, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Liver Cancer
Hepatocellular Carcinoma
Intervention: Radiation: Proton radiation therapy

  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
Patients with a diagnosis of hepatocellular carcinoma were recruited from the hepatology clinic at Loma Linda University Medical Center to participate in this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with documented metastatic disease were excluded from this trial.

Reporting Groups
  Description
Proton Beam Therapy Patients received 63Gy in three weeks with proton beam.

Participant Flow:   Overall Study
    Proton Beam Therapy
STARTED   76 
COMPLETED   76 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Proton Beam Therapy Patients received 63Gy in three weeks with proton beam.

Baseline Measures
   Proton Beam Therapy 
Overall Participants Analyzed 
[Units: Participants]
 76 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   39 
>=65 years   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.7  (5.8) 
Gender 
[Units: Participants]
 
Female   23 
Male   53 
Region of Enrollment 
[Units: Participants]
 
United States   76 


  Outcome Measures
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1.  Primary:   3-year Survival Without Tumor Progression for Patients Within the Milan Criteria   [ Time Frame: 3 months ]

2.  Primary:   Median Survival Without Tumor Progression   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Bush MD
Organization: Radiation Medicine - Loma Linda University Medical Center
phone: 909-558-4280
e-mail: dbush@dominion.llumc.edu


Publications of Results:

Responsible Party: David Bush, Loma Linda University
ClinicalTrials.gov Identifier: NCT00614913     History of Changes
Other Study ID Numbers: OSR #48095
First Submitted: December 26, 2007
First Posted: February 13, 2008
Results First Submitted: June 29, 2011
Results First Posted: August 20, 2012
Last Update Posted: August 20, 2012