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Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma
This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine if stereotactic body radiation therapy (SBRT) improves overall survival in hepatocellular carcinoma (HCC) patients treated with sorafenib (sorafenib tosylate). SECONDARY OBJECTIVES: I. To determine the difference in time to progression (TTP) and progression-free survival (PFS) in HCC patients treated with sorafenib compared to SBRT followed by sorafenib. II. To measure differences in toxicity in HCC patients treated with sorafenib versus SBRT followed by sorafenib. III. To measure vascular thrombosis response post sorafenib versus SBRT followed by sorafenib. IV. To measure differences in health related quality of life (QOL) and quality-adjusted survival in HCC patients treated with sorafenib compared to SBRT followed by sorafenib. V. Collection of biospecimens for future correlative studies to investigate differences in potential biomarkers in patients treated with sorafenib versus SBRT followed by sorafenib.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Saint Vincent's Medical Center
Bridgeport, Connecticut, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Start Date
April 1, 2013
Primary Completion Date
July 1, 2022
Completion Date
September 4, 2025
Last Updated
January 28, 2026
193
ACTUAL participants
Sorafenib
DRUG
stereotactic body radiation therapy
RADIATION
Lead Sponsor
Radiation Therapy Oncology Group
Collaborators
NCT02088775
NCT01624285
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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