Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT00614913 |
Recruitment Status :
Completed
First Posted : February 13, 2008
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cancer Hepatocellular Carcinoma | Radiation: Proton radiation therapy | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma |
Study Start Date : | May 1998 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614913
United States, California | |
Loma Linda University Medical Center / James M. Slater Proton Treatment Center | |
Loma Linda, California, United States, 92354 |
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 |
Responsible Party: | David Bush, Principal Inverstigator, Loma Linda University |
ClinicalTrials.gov Identifier: | NCT00614913 |
Other Study ID Numbers: |
OSR #48095 |
First Posted: | February 13, 2008 Key Record Dates |
Results First Posted: | August 20, 2012 |
Last Update Posted: | August 20, 2012 |
Last Verified: | July 2012 |
Proton Radiotherapy Hepatocellular carcinoma Liver Cancer |
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 |