Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

Loma Linda University (LLU)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatocellular Carcinoma

Liver Cancer

Treatments

Radiation: Proton radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00614913

OSR #48095

Details and patient eligibility

About

This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.

Full 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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.