Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00532740|
Recruitment Status : Recruiting
First Posted : September 20, 2007
Last Update Posted : January 8, 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 metastatic liver cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment|
|Liver Cancer Metastatic Cancer||Radiation: Yttrium Y 90 glass microspheres|
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients who are not candidates for surgical resection of metastatic intrahepatic carcinoma.
- Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres 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 therapy 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study therapy, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver|
|Study Start Date :||December 2004|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2019|
Patients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care.
Radiation: Yttrium Y 90 glass microspheres
Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.
- Patient experience and toxicity associated with TheraSphere® treatment [ Time Frame: During & at completion of treatment. ]Evaluate patient experience and toxicities associated with TheraSphere® treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532740
|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|