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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center Identifier:
First received: January 3, 2008
Last updated: November 4, 2015
Last verified: November 2015

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 yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

Condition Intervention Phase
Liver Cancer
Radiation: brachytherapy
Radiation: yttrium Y 90 glass microspheres
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

Resource links provided by NLM:

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Access to treatment [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
  • Patient experience associated with treatment [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: Yes ]
  • Liver database [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: April 2007
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (radiation therapy)
Patients receive yttrium Y 90 glass microspheres via hepatic arterial infusion. Beginning 4-12 weeks later, some patients may receive additional treatment courses.
Radiation: brachytherapy
The target dose of TheraSphere® is 80-150Gy
Radiation: yttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150Gy

Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of hepatocellular carcinoma
  • Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
  • Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  • Absolute granulocyte count =<1,500/ul
  • Platelet count =<75,000/ul
  • Serum creatinine >= 2.0 mg/dl
  • Serum bilirubin * >= 2.0 mg/dl for bilateral treatment or lobar treatment * > 3.0 mg/dl for single lesion which could be treated by segmental fusion
  • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
  • Bleeding, diathesis not correctable by usual forms of therapy
  • Severe peripheral vascular disease that would preclude catheterization
  • Portal hypertension with portal venous shunt away from the liver
  • Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments
  • Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Pregnant women may not participate
  • Children may not participate
  Contacts and Locations
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Please refer to this study by its identifier: NCT00589030

United States, California
City of Hope Medical Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Yi-Jen Chen, MD, PhD City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center Identifier: NCT00589030     History of Changes
Other Study ID Numbers: 06057  P30CA033572  CHNMC-06057  CDR0000579146  NCI-2010-00429 
Study First Received: January 3, 2008
Last Updated: November 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on May 23, 2016