Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors
Completed · Phase 1/Phase 2
Conditions studied: Carcinoma, Hepatocellular, Liver Neoplasms
In brief
The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity. The study has the following objectives: * Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver. * Evaluate patient experience and toxicities associated with TheraSphere treatment * Evaluate predisposing factors that may influence results and toxicity
Key facts
- Study ID
- NCT00493883
- Run by
- Southwestern Regional Medical Center
- People needed
- 81
- Starts
- 2006-12-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2015-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >= 18.
- Cancer visible in liver on CT,MR,US or PET scan.
- Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma.
- Life expectancy greater than 2 months
- Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.)
- Patients have tried and/or are aware of all FDA approved therapies for their condition.
You may not qualify if…
- Vascular shunt that cannot be corrected.
- Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body.
- Pregnancy
- Hematologic primary such as lymphoma, leukemia, myeloma.
- Body weight 300 lbs. and above
- Evidence of portal hypertension, splenomegaly or ascites.
Where it is running
- Cancer Treatment Centers of America at Southwestern Regional Medical Center — Tulsa, Oklahoma, United States
Full record on ClinicalTrials.gov
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