Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

Phase 1

Completed

• Conditions: Liver Cancer; Hepatocellular Carcinoma

• Registration Number: NCT00614913
• Lead Sponsor: Loma Linda University

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 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 Timeline

• Study Start: 1998-05
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2011-06-29
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-16
• Last Update Submitted: 2012-07-16
• Results First Posted: 2012-08-20
• Last Update Posted: 2012-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria	3 months	Percent of participants alive and without tumor progression 3 years following treatment.
Median Survival Without Tumor Progression	3 months	Median time until disease progression or death

Trial Locations

Locations (1)

Loma Linda University Medical Center / James M. Slater Proton Treatment Center; 🇺🇸 Loma Linda, California, United States