Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614913
• Other study ID #: OSR #48095
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms

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