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

December 26, 2007
July 16, 2012
May 1998
February 2009   (final data collection date for primary outcome measure)
  • 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
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 ]
Complete list of historical versions of study NCT00614913 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cancer
  • Hepatocellular Carcinoma
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
February 2009
February 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00614913
OSR #48095
Yes
David Bush, Loma Linda University
Loma Linda University
Not Provided
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
Loma Linda University
July 2012

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