Proton Beam Therapy for Treatment of Hepatocellular Carcinoma - Full Text View

Purpose

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

Condition	Intervention	Phase
Liver Cancer Hepatocellular Carcinoma	Radiation: Proton radiation therapy	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Liver Cancer

Genetic and Rare Diseases Information Center resources: Liver Cancer

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:

3-year Survival Without Tumor Progression for Patients Within the Milan Criteria [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Percent of participants alive and without tumor progression 3 years following treatment.
Median Survival Without Tumor Progression [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Median time until disease progression or death


Enrollment:	76
Study Start Date:	May 1998
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614913

Locations


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

Sponsors and Collaborators

Loma Linda University

Investigators


Principal Investigator:	David A Bush, MD	Loma Linda University Dept. of Radiation Medicine
Study Chair:	Jerry D Slater, MD	Loma Linda University Department of Radiation Medicine

More Information

Publications:

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.

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.


Responsible Party:	David Bush, Principal Inverstigator, Loma Linda University
ClinicalTrials.gov Identifier:	NCT00614913 History of Changes
Other Study ID Numbers:	OSR #48095
Study First Received:	December 26, 2007
Results First Received:	June 29, 2011
Last Updated:	July 16, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Loma Linda University:


Proton Radiotherapy Hepatocellular carcinoma Liver Cancer

Additional relevant MeSH terms:


Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms	Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases

ClinicalTrials.gov processed this record on September 30, 2016