Phase 3 Prospective, Randomized, Blinded And Controlled Investigation Of Hepasphere/Quadrasphere Microspheres For Delivery Of Doxorubicin For The Treatment Of Hepatocellular Cancer
ID Number 11-0933Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to compare and evaluate the effects of injection of chemotherapy (which is a standard treatment) with two different particles. Both QuadaSphere and particle PVA are cleared by the FDA for use in hypervascularized tumors. The use of QuadraSpheres to deliver a drug such as doxorubicin is investigational. The main purpose of this study is to find out if the use of QuadraSphere adds to the effectiveness of chemoembolization. Effectiveness will be defined by improved survival. In this study, we will also evaluate the degree of tumor destruction (necrosis) and the rate of adverse events in the two treatment groups.
Recruiting Patients: Yes