Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

David Bush, Loma Linda University

ClinicalTrials.gov Identifier:

NCT00614913

First received: December 26, 2007

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

July 16, 2012

Start Date ^ICMJE

May 1998

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To determine the over-all survival, disease specific survival, recurrence rates, and toxicities associated with proton treatment. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00614913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

To determine the response rate of HCC to proton therapy and evaluate its ability to provide bridging therapy for patients receiving liver transplantation. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Liver Cancer
Hepatocellular Carcinoma

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00614913

Other Study ID Numbers ^ICMJE

OSR #48095

Has Data Monitoring Committee

Yes

Responsible Party

David Bush, Loma Linda University

Study Sponsor ^ICMJE

Loma Linda University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Loma Linda University

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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