Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
Recruitment status was: Recruiting
|Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer||Radiation: yttrium Y 90 glass microspheres Other: laboratory biomarker analysis|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma|
- Response to treatment [ Time Frame: Up to 2 years ]
- Survival time [ Time Frame: Up to 2 years ]
- Adverse experiences [ Time Frame: Up to 2 years ]
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (yttrium Y 90 glass microspheres)
Patients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
Radiation: yttrium Y 90 glass microspheres
Other Name: TheraSphereOther: laboratory biomarker analysis
I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. 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 up at 3-6 weeks and annually for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02072356
|Contact: Ohio State University Comprehensive Cancer Center||1-800-293-5066||Jamesline@osumc.edu|
|Contact: Hooman Khabiri, MD||614-293-9508||Hooman.Khabiri@osumc.edu|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Hooman Khabiri, MD 614-293-2773 Hooman.Khabiri@osumc.edu|
|Principal Investigator: Hooman Khabiri, MD|
|Principal Investigator:||Hooman Khabiri||Ohio State University Comprehensive Cancer Center|