A Phase III Study of Second-Line Chemotherapy with and without TheraSphere to Treat Liver Metastases from Colorectal Cancer

Full Title

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

Purpose

Doctors usually treat colorectal cancer metastases with a combination of chemotherapy drugs. When tumors continue to grow or come back, a second regimen of chemotherapy drugs, called "second-line treatment," is the standard care. In this study, researchers want to see if adding a treatment called TheraSphere to second-line chemotherapy is more effective than the chemotherapy alone in certain patients with colorectal cancer liver metastases.

TheraSphere involves the injection of tiny pellets that release cancer-killing radiation directly to liver tumors. They are inserted into the blood vessels supplying the liver. TheraSphere is already used to treat primary liver cancer; its use in this study is considered investigational.

Patients will be randomly assigned to receive second-line chemotherapy alone, or second-line chemotherapy in which one cycle of chemotherapy is replaced by a TheraSphere treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable liver metastases from colorectal cancer that have continued to grow despite initial therapy that included oxaliplatin or irinotecan.
  • Patients must be eligible to receive second-line chemotherapy treatment that includes oxaliplatin or irinotecan.
  • Initial chemotherapy must be completed within 2 weeks of entering the study.
  • Patients may not have had prior radiation treatment to the liver.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Constantinos Sofocleous at 212-639-3379.

Protocol

16-936

Phase

III

Disease Status

Relapsed or Refractory

Co-Investigators

Locations