Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Liver Cancer Hepatocellular Carcinoma Radiation: Proton radiation therapy Phase 1 Phase 2

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
Study Start Date : May 1998
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • 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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. Median Survival Without Tumor Progression [ Time Frame: 3 months ]
    Median time until disease progression or death


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614913


Locations
Layout table for location information
United States, California
Loma Linda University Medical Center / James M. Slater Proton Treatment Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: David Bush, Principal Inverstigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT00614913    
Other Study ID Numbers: OSR #48095
First Posted: February 13, 2008    Key Record Dates
Results First Posted: August 20, 2012
Last Update Posted: August 20, 2012
Last Verified: July 2012
Keywords provided by David Bush, Loma Linda University:
Proton
Radiotherapy
Hepatocellular carcinoma
Liver Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases