Status:
COMPLETED
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
Lead Sponsor:
Loma Linda University
Conditions:
Liver Cancer
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
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 pat...
Eligibility Criteria
Inclusion
- Diagnosis of hepatocellular carcinoma
- Adult patients aged 18 years old and above
- Ability to give informed consent for study
- Compensated liver disease
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00614913
Start Date
May 1 1998
End Date
February 1 2009
Last Update
August 20 2012
Active Locations (1)
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1
Loma Linda University Medical Center / James M. Slater Proton Treatment Center
Loma Linda, California, United States, 92354