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Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular Carcinoma

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:
A Humanitarian Device Exemption Treatment Protocol of TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

Clinical Trial Summary

This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates. II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment. OUTLINE: Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Hepatocellular
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Unresectable Hepatocellular Carcinoma
Clinical Trial Details
NCT number NCT01176604
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase N/A
Start date August 4, 2010
Completion date April 9, 2021
View Details
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