Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (STOP-HCC)
This study is currently recruiting participants.
Verified May 2013 by Nordion (Canada) Inc.
Sponsor:
Nordion (Canada) Inc.
Information provided by (Responsible Party):
Nordion (Canada) Inc.
ClinicalTrials.gov Identifier:
NCT01556490
First received: March 13, 2012
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.
| Condition | Intervention | Phase |
|---|---|---|
|
Unresectable Hepatocellular Carcinoma |
Device: TheraSphere |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC) |
Resource links provided by NLM:
Further study details as provided by Nordion (Canada) Inc.:
Primary Outcome Measures:
- Overall survival [ Time Frame: From time of randomization up to 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control group
Standard-of-care sorafenib, with no added therapy
|
|
|
Experimental: Treatment group
Standard-of-care sorafenib plus TheraSphere
|
Device: TheraSphere
Yttrium 90 microspheres
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unresectable advanced HCC not amenable to curative procedures, with planned standard-of-care sorafenib therapy
Exclusion Criteria:
- Main portal vein thrombosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556490
Contacts
| Contact: Medha Kelkar, MPharm, PMP | 905-403-9901 ext 2667 | medha.kelkar@theoremclinical.com |
Locations
| United States, Arizona | |
| Banner Good Samaritan Medical Center | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Kelly Enders 602-839-0427 kelly.enders@bannerhealth.com | |
| Principal Investigator: David Wood, MD | |
| United States, Florida | |
| H Lee Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Bonnie Sauder, RN 813-745-3574 bonnie.sauder@moffitt.org | |
| Principal Investigator: Jennifer Sweeney, MD | |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Carlene del Castillo 312-695-1409 carlene.castillo@northwestern.edu | |
| Principal Investigator: Laura Kulik, MD | |
| United States, Indiana | |
| Indiana University School of Medicine | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Marsha Hughes-Gay 812-348-7326 mhughesg@iupuc.edu | |
| Principal Investigator: Matthew S Johnson, MD | |
| United States, Kentucky | |
| University of Louisville | Not yet recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Susan Ellis, RN, OCN 502-629-3384 susan.ellis@louisville.edu | |
| Principal Investigator: Robert Martin, MD, PhD | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Ann Marie Ferris 313-576-9373 ferrisa@karmanos.org | |
| Principal Investigator: Minsig Choi, MD | |
| United States, Oregon | |
| Legacy Meridian Park Medical Center | Recruiting |
| Tualatin, Oregon, United States, 97062 | |
| Contact: Susan Staat 503-413-8330 sstaat@lhs.org | |
| Principal Investigator: Jason Bauer, MD | |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Nancy Pedano, RTR,CVR,RA 215-955-4129 nancy.pedano@jefferson.edu | |
| Principal Investigator: Daniel B Brown, MD | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Jolene Esposito 434-982-5037 jle2u@virginia.edu | |
| Principal Investigator: James Stone, MD | |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Obsy Tadesse 206-288-6439 otadesse@seattle.ca.org | |
| Principal Investigator: Siddharth Padia, MD | |
| Principal Investigator: William P Harris, MD | |
| Canada, Alberta | |
| University of Alberta Hspital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Joanne McGoey (780) 407 6912 joanne.mcgoey@albertahealthservices.ca | |
| Principal Investigator: Richard Owen, MD | |
| Canada, Quebec | |
| McGill University Health Centre / Royal Victoria Hospital | Recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Contact: Ayat Salman (514) 934-1934 ext 36237 Ayat.Salman@MUHC.MCGILL.CA | |
| Principal Investigator: David Valenti, MD | |
| France | |
| Centre Eugene Marquis | Recruiting |
| Rennes, France, 35042 cedex | |
| Principal Investigator: Eveline Boucher, MD | |
Sponsors and Collaborators
Nordion (Canada) Inc.
Investigators
| Principal Investigator: | Riad Salem, MD, MBA | Dept of Radiology Northwestern University |
More Information
No publications provided
| Responsible Party: | Nordion (Canada) Inc. |
| ClinicalTrials.gov Identifier: | NCT01556490 History of Changes |
| Other Study ID Numbers: | TS-103 |
| Study First Received: | March 13, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 18, 2013