Clinical Trials Directory

Trials / Completed

CompletedNCT01176604

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
299 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
RADIATIONYttrium Y 90 Glass MicrospheresGiven via catheter

Timeline

Start date
2010-08-04
Primary completion
2021-04-09
Completion
2021-04-09
First posted
2010-08-06
Last updated
2022-10-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01176604. Inclusion in this directory is not an endorsement.