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Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00589030
Recruitment Status : No longer available
First Posted : January 9, 2008
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

January 3, 2008
January 9, 2008
February 15, 2017
 
Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

  • Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
  • Evaluate patient experience and toxicities associated with TheraSphere® treatment.
  • Enter treatment experience into a liver database.

Secondary

  • Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.

Expanded Access
  • Radiation: brachytherapy
    The target dose of TheraSphere® is 80-150Gy
  • Radiation: yttrium Y 90 glass microspheres
    The target dose of TheraSphere® is 80-150Gy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00589030
City of Hope Medical Center
City of Hope Medical Center
Not Provided
Principal Investigator: Yi-Jen Chen, MD, PhD City of Hope Medical Center
City of Hope Medical Center
February 2017