Spots Global Cancer Trial Database for Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
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Trial Identification
Brief Title: Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
Official Title: Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma
Study ID: NCT01730937
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Decatur Memorial Hospital, Decatur, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Columbia University/Herbert Irving Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
M D Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
University of Vermont Medical Center, Burlington, Vermont, United States
Hunter Holmes McGuire Veterans Administration Medical Center, Richmond, Virginia, United States
ProCure Proton Therapy Center-Seattle, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre (MUHC), Montreal, Quebec, Canada
Pamela Youde Nethersole Eastern Hospital, Chai Wan, , Hong Kong
Samsung Medical Center, Seoul, Korea, Korea, Republic of
Contact Details
Name: Laura Dawson
Affiliation: Radiation Therapy Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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