A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy

ID Number 12-1658

Principal Investigator(s)
Randall Holcombe

Department(s) or Division(s)
Hematology and Medical Oncology

Description

The purpose of this study is to examine whether adding treatment with TheraSphere early in the current standard for second-line chemotherapy treatment of metastatic colorectal cancer is better than the current treatment alone. Better means slowing or stopping the growth of liver tumors without experiencing a significant increase in number or severity of side effects. You are being asked to voluntarily participate in this study because you have been diagnosed and need treatment for cancer in your liver that cannot be removed by surgery.  There are no other treatments being evaluated in this study.

TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors.  Y-90 is incorporated into very tiny glass beads (TheraSphere), and is injected into the liver through the blood vessels supplying blood to the liver.  The goal of treatment with TheraSphere is to allow a large dose of radiation to be delivered directly to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue compared with currently available treatments.  TheraSphere has restricted approval from United States Food and Drug Administration (FDA) for the treatment of primary liver cancer.

You may qualify to take part in this research study because you have cancer in your liver that has spread from the colon or rectum, also called metastatic colorectal cancer. TheraSphere is a medical device approved in the United States for the treatment of liver cancer called hepatocellular carcinoma.  It consists of millions of microscopic glass spheres that are injected into the main artery in the liver to deliver radiation therapy directly to the tumor.

Colorectal cancer is treated with combinations of chemotherapy agents, most frequently including drugs called oxaliplatin or irinotecan. You have completed your first series of chemotherapy treatment and your doctor is planning to use a second combination of drugs to continue your cancer treatment. This is called second-line chemotherapy.

The purpose of this study is to see if adding TheraSphere treatment at the beginning of second-line chemotherapy extends survival time and is safe.



Contact Information
Kiev Gimpel-Tetra
(212) 824-7117


Recruiting Patients: Yes