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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614913
Other study ID # OSR #48095
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 26, 2007
Last updated July 16, 2012
Start date May 1998
Est. completion date February 2009

Study information

Verified date July 2012
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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


Intervention

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.

Locations

Country Name City State
United States Loma Linda University Medical Center / James M. Slater Proton Treatment Center Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary Median Survival Without Tumor Progression Median time until disease progression or death 3 months Yes
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