Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00530010|
Recruitment Status : Recruiting
First Posted : September 17, 2007
Last Update Posted : June 4, 2018
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 how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment|
|Liver Cancer||Radiation: yttrium Y 90 glass microspheres|
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection.
- Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) treatment.
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma|
|Study Start Date :||December 2004|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
- Radiation: yttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.
- Proportion of patients completing scheduled treatment plan [ Time Frame: At point that patient discontinues treatment for whatever reason. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530010
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Recruiting|
|Chicago, Illinois, United States, 60611-3013|
|Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 email@example.com|
|Study Chair:||Riad Salem, MD||Robert H. Lurie Cancer Center|