Phase II Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres As First-Line Treatment For Cholangiocarcinoma
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 when compared with currently available treatments.
The standard treatment for cholangiocarcinoma is surgery (if possible), external beam
radiation therapy and/or chemotherapy. External beam radiation therapy to the liver may
reduce symptoms, but only 20% of patients experience significant tumor shrinkage.
Chemotherapy has response rates ranging from 6-19%. More recently, a new approach has been
developed, called TheraSphere. Based on the results of earlier studies with TheraSphere, the
study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for
TheraSphere has restricted approval from the United States Food and Drug Administration
(FDA) for the treatment of hepatocellular liver cancer; but it has not yet been approved for
the treatment of cholangiocarcinoma. 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 called microspheres and is injected
into the liver through the blood vessels supplying the liver.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Progression Free Survival (PFS)
PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe.
At 1 Month, 3 Months, every 3 Months for life
Ravi Shridhar, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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