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

December 26, 2007
February 13, 2008
June 29, 2011
August 20, 2012
August 20, 2012
May 1998
February 2009   (Final data collection date for primary outcome measure)
  • 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria [ Time Frame: 3 months ]
    Percent of participants alive and without tumor progression 3 years following treatment.
  • Median Survival Without Tumor Progression [ Time Frame: 3 months ]
    Median time until disease progression or death
To determine the over-all survival, disease specific survival, recurrence rates, and toxicities associated with proton treatment. [ Time Frame: Monthly ]
Complete list of historical versions of study NCT00614913 on Archive Site
Not Provided
To determine the response rate of HCC to proton therapy and evaluate its ability to provide bridging therapy for patients receiving liver transplantation. [ Time Frame: Monthly ]
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Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.
Hepatocellular carcinoma (HCC) is a type of primary cancer of the liver that is being diagnosed in the U.S. population with increasing frequency. While surgery is the first line of treatment, many patients are not eligible for surgical removal. Current non-surgical treatments for HCC are not fully effective and can have substantial side-effects. This study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. The treatment is non-invasive and is given on an out-patient basis over a three week coarse. The study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Cancer
  • Hepatocellular Carcinoma
Radiation: Proton radiation therapy
A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of hepatocellular carcinoma
  • Adult patients aged 18 years old and above
  • Ability to give informed consent for study
  • Compensated liver disease

Exclusion Criteria:

  • Pediatric patients (aged less than 18 years old)
  • Decompensated or advanced liver disease
  • Poorly controlled ascites
  • Variceal hemorrhage within the previous 30 days
  • Recurrent hepatic encephalopathy
  • Cirrhosis with CTP* score >10
  • Active alcohol or drug abuse
  • Anticipated survival of less than 30 days
  • Advanced co-morbid medical illnesses
  • Karnofsky Performance Score <60

Tumor characteristics:

- Any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
OSR #48095
Not Provided
Not Provided
David Bush, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: David A Bush, MD Loma Linda University Dept. of Radiation Medicine
Study Chair: Jerry D Slater, MD Loma Linda University Department of Radiation Medicine
Loma Linda University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP