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Phase I Study of Selective Internal Radiation Therapy in Patients with Unresectable Colorectal Cancer Liver Metastases Persisting Despite Hepatic Arterial Chemotherapy

[Protocol 09-030]


Full Title :
PHASE I STUDY OF SELECTIVE INTERNAL RADIATION THERAPY (SIRT) IN PATIENTS WITH UNRESECTABLE COLORECTAL CANCER LIVER METASTASES WHO FAILED PRIOR INTRARTERIAL PUMP CHEMOTHERAPY
Purpose :

The purpose of this study is to evaluate the safety and effectiveness of a new therapy called "selective internal radiation therapy" (SIRT) in patients with liver metastases from colorectal cancer whose tumors persist despite prior hepatic arterial chemotherapy.

The radiation in SIRT is delivered in SIR-spheres -- tiny beads containing a radioactive agent called yttrium-90. These beads can be delivered through a small tube inserted into the blood vessel that goes directly to the tumor. Radiation goes directly to the tumor, thereby sparing healthy liver tissue.

Eligibility :

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

  • Patients must have colorectal cancer that has metastasized to the liver.
  • Patients' liver metastases must be inoperable and persist despite prior hepatic arterial chemotherapy.
  • At least 4 weeks must have passed since the last chemotherapy treatment and receipt of SIRT.
  • Patients may not have had prior radiation therapy 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.
  • Patients must be age 18 or older.

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

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