Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Study Completion Date

2009-02-28

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.

Conditions

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Liver Cancer Hepatocellular Carcinoma

Keywords

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Proton Radiotherapy Hepatocellular carcinoma Liver Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type RADIATION

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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David Bush

Principal Inverstigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Bush, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Dept. of Radiation Medicine

Jerry D Slater, MD

Role: STUDY_CHAIR

Loma Linda University Department of Radiation Medicine

Locations

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Loma Linda University Medical Center / James M. Slater Proton Treatment Center

Loma Linda, California, United States

Site Status

Countries

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United States

References

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Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial. Gastroenterology. 2004 Nov;127(5 Suppl 1):S189-93. doi: 10.1053/j.gastro.2004.09.033.

Reference Type RESULT

PMID: 15508084 (View on PubMed)

Bush DA, Kayali Z, Grove R, Slater JD. The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer. 2011 Jul 1;117(13):3053-9. doi: 10.1002/cncr.25809. Epub 2011 Jan 24.