Nordion has received FDA approval to conduct a Phase III clinical trial to evaluate TheraSphere under an investigational device exemption as a treatment for colorectal cancer patients whose disease has metastasized to the liver. This randomized clinical trial, known as the EPOCH study, will take place at up to 30 sites worldwide and enroll approximately 350 patients.
EPOCH will examine a number of safety and efficacy endpoints in patients who have developed liver tumors from colorectal cancer and who have failed first-line chemotherapy. Participants in the treatment group will receive both TheraSphere and second-line chemotherapy, while patients in the control group will only receive the chemotherapy regimen, according to a company statement.
According to the U.S. National Cancer Institute, colorectal cancer is the third most common cancer in both men and women. An estimated 60 percent of CRC patients will eventually develop liver tumors. Most deaths associated with CRC are due to inoperable liver tumors, the company says.
- see the Nordion release