Liver Cancer Clinical Trial
Official title:
The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near
a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be
effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: This phase II trial is studying the side effects of hepatic arterial infusion using
yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with
liver cancer that cannot be removed by surgery.
OBJECTIVES:
- Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients
with unresectable hepatocellular carcinoma.
- Determine the response in patients with unresectable hepatocellular carcinoma treated
with hepatic arterial infusion of yttrium-90 glass microspheres.
- Determine the toxic effects and adverse experiences associated with this therapy in
these patients.
- Determine the survival time of patients treated with this therapy.
- Determine the time to progression of disease in the liver, duration of response, and
progression-free interval of patients treated with this therapy.
- Evaluate the influence of pretreatment characteristics on efficacy parameters in
patients treated with this therapy.
- Assess the quality of life of patients treated with this therapy.
OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused
directly into a liver tumor in order to kill tumor cells and cause less damage to the normal
tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is
accessed through the femoral artery in the groin. This procedure is generally completed on
an outpatient basis. Patients may receive a single dose to the whole liver, or sequential
treatments to each side of the liver approximately 30 to 90 days apart. Patients may be
re-treated at a later time.
Patients are followed every 2 to 4 months for the rest of their lives to access tumor
progression, symptom management and quality of life.
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