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 drugs being used in this study are as follows:
• All patients will receive doxorubicin, an anti-cancer drug.
• Half the patients will also receive iodized oil mixed with doxorubicin.
The devices used in this study are as follows:
• QuadraSphere Microspheres: These are small particles that can absorb the chemotherapy and release the drug into the tumor over time while they block the blood flow to the tumor. No oil will be used with this product.
• Particle (non-spherical) PVA: These are small particles that act as a plug to keep the chemotherapy and oil in the artery while they block the blood flow to the tumor.
The purpose of this study is to compare and evaluate the effects of injection of chemotherapy (which is a standard treatment) with the two different particles. Both QuadaSphere and particle PVA are cleared by the FDA for use in hypervascularized tumors. Your liver cancer is a type of hypervascularized (having extra blood vessels) tumor. 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 the 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. You will have an equal chance of being put into either treatment group.
You may qualify to take part in this research study because you have cancer in your liver that your doctor has determined may be treated with a procedure called transarterial chemoembolization (TACE).
Recruiting Patients: Yes