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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
  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: Cancer 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:
    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.
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
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:

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

ClinicalTrials.gov processed this record on March 01, 2015