Spots Global Cancer Trial Database for Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer
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Trial Identification
Brief Title: Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer
Official Title: A Phase II Randomized Multicenter Placebo-Controlled Blinded Study of Sorafenib Adjuvant Therapy in High Risk Orthotopic Liver Transplant (OLT) Recipients With Hepatocellular Carcinoma (HCC)
Study ID: NCT01624285
Study Description
Brief Summary: The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation. Liver transplantation is a treatment option for liver cancer patients, but despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not known whether sorafenib is effective in preventing cancer recurrence in high risk patients following liver transplantation
Detailed Description: PRIMARY OBJECTIVES: I. Two-year recurrence free survival (RFS). SECONDARY OBJECTIVES: I. One-year recurrence free survival. II. Overall survival (OS). III. Safety. IV. Impact of drug-drug interactions (i.e. immunosuppression agents). V. Impact of biomarkers (alpha-fetoprotein \[AFP\], protein-induced by vitamin K absence or antagonist II \[PIVKA II\]). VI. Effects of therapy on wound healing. VII. Impact of hepatitis C viral recurrence. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sorafenib tosylate orally (PO) twice daily (BID). ARM II: Patients receive placebo PO BID. In both arms treatment continues for 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
University of Colorado, Denver, Colorado, United States
Mount Sinai Hospital, Hartford, Connecticut, United States
Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia, United States
Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
Lahey Clinic Medical Center, Burlington, Massachusetts, United States
University of Michigan University Hospital, Ann Arbor, Michigan, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
University of Pennsylvania Health System, Cherry Hill, New Jersey, United States
New York University Langone Medical Center, New York, New York, United States
New York Presbyterian-The University Hospital of Columbia and Cornell, New York, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Integris-Baptist Medical, Oklahoma City, Oklahoma, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
Baylor College of Medicine, Houston, Texas, United States
The Methodist Hospital Research Institute, Houston, Texas, United States
Contact Details
Name: Ronald Busuttil
Affiliation: Jonsson Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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