Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors
This study will use angiographic administration of radioactive TheraSphere® Yttirum-90
microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer
involving the liver. The study population are those who have failed standard therapies,
have a majority of their cancer in the liver, have a good performance status and reasonable
hepatic function. Outcomes being studied are response to treatment, survival and toxicity.
1. Range of patients who can be offered TheraSphere®
2. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
3. Survival time
4. Determine response in relation to histology and other parameters
5. Ability to tolerate repeat treatments
6. Toxicity, which may include radiation induced liver damage, pain, consequences of
shunting, toxic deaths.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
2 to 3 months after treatment(s) up to 2 years
No
James P Flynn, MD
Principal Investigator
Southwestern Regional Medical Center
United States: Institutional Review Board
CTCT 06-11
NCT00493883
December 2006
December 2011
Name | Location |
---|---|
Cancer Treatment Centers of America at Southwestern Regional Medical Center | Tulsa, Oklahoma 74133-4564 |