Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Bush, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00614913
First received: December 26, 2007
Last updated: July 16, 2012
Last verified: July 2012
Results First Received: June 29, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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
Study First Received: December 26, 2007
Results First Received: June 29, 2011
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board