Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
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| ClinicalTrials.gov Identifier: NCT00614913 |
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Recruitment Status :
Completed
First Posted : February 13, 2008
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
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Sponsor:
Loma Linda University
Information provided by (Responsible Party):
David Bush, Loma Linda University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Liver Cancer Hepatocellular Carcinoma | Radiation: Proton radiation therapy | Phase 1 Phase 2 |
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 : | 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 |
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.
Primary Outcome Measures :
- 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 |
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.
Information from the National Library of Medicine
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
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 |
Publications of Results:
| Responsible Party: | David Bush, Principal Inverstigator, Loma Linda University |
| ClinicalTrials.gov Identifier: | NCT00614913 History of Changes |
| 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 |
Keywords provided by David Bush, Loma Linda University:
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Proton Radiotherapy Hepatocellular carcinoma Liver Cancer |
Additional relevant MeSH terms:
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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 |