Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma

Conditions
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Liver Cancer, Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: Proton radiation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton, Radiotherapy, Hepatocellular carcinoma, Liver Cancer