Back to resultsProton Beam Therapy for Treatment of Hepatocellular Carcinoma
Primary Purpose
Liver Cancer, Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Proton, Radiotherapy, Hepatocellular carcinoma, Liver Cancer
Eligibility 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.
Sites / Locations
- Loma Linda University Medical Center / James M. Slater Proton Treatment Center
Outcomes
Primary Outcome Measures
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
Percent of participants alive and without tumor progression 3 years following treatment.
Median Survival Without Tumor Progression
Median time until disease progression or death
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00614913
Brief Title
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
Official Title
Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Hepatocellular Carcinoma
Keywords
Proton, Radiotherapy, Hepatocellular carcinoma, Liver Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Proton radiation therapy
Intervention Description
A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.
Primary Outcome Measure Information:
Title
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
Description
Percent of participants alive and without tumor progression 3 years following treatment.
Time Frame
3 months
Title
Median Survival Without Tumor Progression
Description
Median time until disease progression or death
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Bush, MD
Organizational Affiliation
Loma Linda University Dept. of Radiation Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerry D Slater, MD
Organizational Affiliation
Loma Linda University Department of Radiation Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University Medical Center / James M. Slater Proton Treatment Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15508084
Citation
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. doi: 10.1053/j.gastro.2004.09.033.
Results Reference
result
PubMed Identifier
21264826
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.
Results Reference
result
Learn more about this trial
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
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