Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma|
- Proportion of patients completing scheduled treatment plan [ Time Frame: At point that patient discontinues treatment for whatever reason. ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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.
|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|