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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer, Hepatocellular Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year Survival Without Tumor Progression for Patients Within the Milan Criteria

Outcome Description:

Percent of participants alive and without tumor progression 3 years following treatment.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

David A Bush, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Dept. of Radiation Medicine

Authority:

United States: Institutional Review Board

Study ID:

OSR #48095

NCT ID:

NCT00614913

Start Date:

May 1998

Completion Date:

February 2009

Related Keywords:

  • Liver Cancer
  • Hepatocellular Carcinoma
  • Proton
  • Radiotherapy
  • Hepatocellular carcinoma
  • Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location
Loma Linda University Medical Center / James M. Slater Proton Treatment Center Loma Linda, California  92354