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 : 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 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 :||May 2019|
|Estimated Study Completion Date :||April 2020|
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.
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): 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 firstname.lastname@example.org|
|Study Chair:||Riad Salem, MD||Robert H. Lurie Cancer Center|