Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol
4 other identifiers
expanded_access
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 3, 2008
CompletedFirst Posted
Study publicly available on registry
January 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 15, 2017
February 1, 2017
7.4 years
January 3, 2008
February 13, 2017
Conditions
Keywords
Interventions
The target dose of TheraSphere® is 80-150Gy
The target dose of TheraSphere® is 80-150Gy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- first TheraSphere administration; or
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010-3000, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Jen Chen, MD, PhD
City of Hope Medical Center
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2008
First Posted
January 9, 2008
Study Start
April 1, 2007
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 15, 2017
Record last verified: 2017-02