Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT02072356|
Recruitment Status : Recruiting
First Posted : February 26, 2014
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma|
|Actual Study Start Date :||October 11, 2010|
|Estimated Primary Completion Date :||August 31, 2027|
|Estimated Study Completion Date :||August 31, 2027|
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: TheraSphere
Other: laboratory biomarker analysis
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|