Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

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. Identifier: NCT00614913
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Information provided by (Responsible Party):
David Bush, Loma Linda University

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

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

Participant Flow:   Overall Study
    Proton Beam Therapy

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

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

  Outcome Measures

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

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

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

Publications of Results:

Responsible Party: David Bush, Loma Linda University 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