A Phase III Clinical Trial Evaluating TheraSphere in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy (EPOCH)
The purpose of this study is to determine the safety and effectiveness of TheraSphere in treating patients with colorectal cancer with disease progression to the liver.
Patients with colorectal cancer who have disease progression to the liver with first line treatment and are eligible for second line chemotherapy.
TheraSphere is a liver cancer treatment consisting of very small glass beads containing a radioactive element (yttrium-90- an isotope or version of yttrium). TheraSphere is currently approved for use in the United States under a Humanitarian Device Exemption (HDE) (a special FDA approval for devices used to treat rare diseases) for use in patients with primary liver cancer (cancer originating in the liver cells). The beads are delivered via a catheter into the main artery feeding the liver, allowing the treatment to be delivered directly to the tumor(s). This is a randomized clinical trial for candidates scheduled to receive second line chemotherapy. All patients will be treated with standard-of-care chemotherapy; however, patients randomized to the TheraSphere group will receive TheraSphere treatments as well. TheraSphere therapy will be up to but not exceeding two whole liver treatments. Response to therapy will be evaluated every 2 months by clinic visits, MRI/ CT scans and blood tests (to include assessment of liver function and tumor markers). There are various study sites across the United States, Canada and Europe.
04/20/2014 04:02 AM