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Sponsored by: |
Loma Linda University |
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Information provided by: | Loma Linda University |
ClinicalTrials.gov Identifier: | NCT00614913 |
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 |
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Liver Cancer Hepatocellular Carcinoma |
Radiation: Proton radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma |
Estimated Enrollment: | 150 |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
Contact: David A Bush, MD | 909-558-4280 | dbush@dominion.llumc.edu |
United States, California | |
Loma Linda University Medical Center / James M. Slater Proton Treatment Center | Recruiting |
Loma Linda, California, United States, 92354 | |
Principal Investigator: David A. Bush, MD |
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: | Loma Linda University Department of Radiation Medicine ( David A. Bush, MD ) |
Study ID Numbers: | OSR #48095 |
Study First Received: | December 26, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00614913 |
Health Authority: | United States: Institutional Review Board |
Proton Radiotherapy Hepatocellular carcinoma Liver Cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |